Important Safety Information

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Eclipse™ Total Shoulder System

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Indications

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The Arthrex Eclipse shoulder prosthesis is indicated for severely painful and/or disabled joints resulting from osteoarthritis or traumatic arthritis.
The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
The Arthrex titanium humeral head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

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Contraindications

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1. Insufficient quantities or quality of humeral head and/or humeral neck bone stock.
2. A rotator cuff that is not intact and irreparable.
3. Fractures: including irreducible 3- and 4-part proximal humeral fractures and nonunion humeral head fractures of long duration.
4. The use of this device is not suitable as a revision from prior shoulder arthroplasty.
5. Metal allergy.
6. Blood supply limitations and previous infections, which may retard healing.
7. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.
8. Any active infection or blood supply limitations.
9. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period, including severe neuroarthropathy.
10. Do not use for surgeries other than those indicated.
11. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate.

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Adverse Effects

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1. Infections, both deep and superficial.
2. Allergies and other reactions to device materials.
3. Loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear or tissue reaction to the implant. Loosening is frequently a consequence of one or several of the above-listed risk conditions but can also be caused by inadequate anchoring technique (see below).
4. Dislocation, subluxation, or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant.
5. Bone fractures as a result of one-sided overload or weakened bone structure.
6. Temporary or permanent nerve damage as a result of pressure or hematoma.
7. Cardiovascular complications including venous thrombosis, pulmonary embolism, and cardiac arrest.
8. Wound hematoma and delayed wound healing.

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Warnings

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1. Caution: Federal law restricts this device to sale by or on the order of a physician.
2. This device is intended to be used by a trained medical professional.
3. An internal fixation device must never be reused.
4. Do not resterilize this device.
5. A cobalt-chromium implant device contains the following substance(s) defined as CMR 1A and/or CMR 1B and/or endocrine-disrupting substances in a concentration above 0.1% weight by weight:Cobalt; CAS No. 7440-48-4 European Chemicals Agency Database: https:/echa.europa.eu
6. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.
7. Detailed instructions on the use and limitations of this device, the patient leaflet (www.arthrex.com/patientleaflets) and the patient implant card should be given to the patient. Guide the patient in deciding what particular treatment is best for them and explain the benefits, risks, and contraindications associated with the treatment.
8. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Implant removal should be followed by adequate postoperative management.
9. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant, are important considerations in the successful utilization of this device. The appropriate Arthrex delivery system is required for proper implantation of the device.
10. A stemmed prosthesis is recommended for soft/weak bone.
    • It is anticipated that up to 33% of total shoulder candidates lack sufficient bone stock to support a stemless device.
    • If the hollow screw sizer is unstable in the humerus, then this may indicate that the bone is soft/weak.
    • If you can depress thumb into humerus, then this may indicate that the bone is soft/weak.
11. The following operative situations may cause premature loosening and complications:
    • Extreme weakening of the bone structure in preparing the bone bed;
    • Unsuitable selection of the implant size;
    • Inadequate cleaning of the bone bed prior to implantation; and,
    • Excessive use of force in placing or fastening the implant, provoking splintering fractures, or causing the bone to tear.
12. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user.
13. The appropriate Arthrex delivery system is required for proper insertion of the implant.
14. Only Arthrex delivery systems, instruments, and trial prostheses should be used for the implantation procedure.
15. Endoprostheses may not be processed mechanically or changed in any other way.
16. Do not implant any parts that have been scratched or damaged.
17. An artificial joint is subject to wear and/or can loosen over a period of time. Wear and loosening may make it necessary to reoperate on an artificial joint.
18. An infection in an artificial joint may lead to implant removal.
19. This device should only be used in conjunction with other implants designed specifically for use with this system.
20. Titanium plasma-sprayed (TPS)/CaP (calcium phosphate)-coated device - Fluid contact other than patient's blood should be avoided to achieve best ongrowth results.
21. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy.
22. Follow your institutions policy for safe disposal of all needles and other sharps or medical waste.
23. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment should be safely disposed of in accordance with the institution’s policy.
24. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.

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Univers Revers™ Total Shoulder System

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Indications

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The Univers Revers shoulder prosthesis system is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Univers Revers shoulder prosthesis system is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. (Humeral) Stems are intended for cemented or cementless applications for use with Arthrex humeral suture cups. The Universal Glenoid baseplate is CaP-coated and is intended for cementless use with the addition of screws for fixation.

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Contraindications

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1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections, which may retard healing.
3. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Do not use for surgeries other than those indicated.

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Adverse Effects

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1. Infections, both deep and superficial.
2. Foreign body reactions.
3. Injury to nerves, blood vessels, muscles, tendons.
4. Malunion/nonunion of the bone.
5. Necrosis of the humeral head.
6. Risk of chronic pain.
7. Allergies and other reactions to device materials.
8. Loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear and breakage of the cement bed and/or tissue reaction to the implant. Loosening is frequently a consequence of one or several of the above-listed risk conditions, but can also be caused by inadequate anchoring technique (see below).
9. Dislocation, subluxation, or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant.
10. Bone fractures as a result of one-sided overload or weakened bone substance.
11. Temporary or permanent nerve damage as a result of pressure or hematoma.
12. Cardiovascular diseases including venous thrombosis, pulmonary embolism, and cardiac arrest.
13. Wound hematoma and delayed wound healing.
14. Tissue reactions caused by allergic reactions to the implanted material, particularly metal, or caused by accumulations of wear particles or cement particles.

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Warnings

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1. Caution: Federal law restricts this device to sale by or on the order of a physician.
2. This device is intended to be used by a trained medical professional.
3. An internal fixation device must never be reused.
4. Do not resterilize this device.
5. A cobalt-chromium implant device contains the following substance(s) defined as CMR 1A and/or CMR 1B and/or endocrine-disrupting substances in a concentration above 0.1% weight by weight:cobalt; CAS No. 7440-48-4 European Chemicals Agency Database: https://echa.europa.eu/
6. ­­In the Univers Revers system, refer to the surgical technique for implant component compatibility information.
7. 6 mm offset humeral liners must not be used in combination with humeral spacers. Humeral spacers should only be used with 3 mm offset humeral liners.
8. Failure to achieve the appropriate torque requirements when tightening locking screws may result in the premature loosening of the device.
9. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.
10. For detailed instructions on the use and limitations of this device, the patient leaflet (www.arthrex.com/patientleaflets) and the patient implant card should be provided to the patient within markets where patient information is required. Guide the patient in deciding what particular treatment is best for them and explain the benefits, risks, and contraindications associated with the treatment.
11. Any decision to remove the device should take into consideration the potential risk to the patient ofa second surgical procedure. Device removal should be followed by adequate postoperative management.
12. Removal of the device should be performed using standard surgical practices for device removal.
13. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant, are important considerations in the successful utilization of this device. The following operative situations may cause premature loosening and complications:
    • Extreme weakening of the bone structure in preparing the bone bed;·    
    • Unsuitable selection of the implant size;·    
    • Inadequate cleaning of the bone bed prior to implantation; and,·    
    • Excessive use of force in placing or fastening the implant, provoking splintering fractures, or causing the bone to tear.
14. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user.
15. The operation is to be planned based on the preoperative X-rays.
16. The specific Arthrex implantation instruments are to be used both for preparing the bone bed and for adjusting and inserting the joint prosthesis. The appropriate Arthrex delivery system is required for proper insertion of the implant.
17. Only Arthrex delivery systems, instruments, and trial prostheses should be used for the implantation procedure.
18. Endoprostheses may not be processed mechanically or changed in any other way.
19. Do not implant any parts that have been scratched or damaged. An artificial joint is subject to wear and/or can loosen over a period of time. Wear and loosening may make it necessary to re-operate on an artificial joint.
20. An infection in an artificial joint may lead to implant removal.
21. This device should only be used in conjunction with other implants designed specifically for use withthis system.
22. Proper anchoring is of decisive importance for firm, permanent positioning of the prosthesis.
23. CaP-coated device – Fluid contact other than patient’s blood should be avoided to achieve the best ongrowth results.
24. In the case of joint endoprosthesis intended for cemented anchoring, the surgeon must comply with the instructions and recommendations of the cement manufacturer when it comes to preparation and cementing techniques. Failure to properly align and completely seat the components together can lead to disassociation. Proper technique must be followed to ensure there is no bony or soft tissue interference between modular components. All screws must be adequately tightened to ensure they are recessed to prevent a mechanical interference between modular components.
25. Thoroughly clean and dry tapers, prior to attachment of modular components to avoid crevice corrosion and improper seating. Glenosphere forceps are required to verify integrity of the Morse taper connection between glenosphere and baseplate.
26. For augmented modular baseplates with obliquely oriented augments, a minimum of two peripheral screws with lengths of 24 mm or longer must be used if the screw passes through the augment. Any length screw may be used in the remaining peripheral screw holes. Both locking or non-locking screws may be used interchangeably. Arthrex recommends a minimum of two peripheral screws to be used.
27. For augmented modular baseplates with standard (non-obliquely oriented) augments, a minimum of two locking peripheral screws with a length of 24 mm or longer must be used.  The locking screws should be placed within the peripheral screw holes most superior and inferior in orientation and pass through the maximum thickness of the augment. Any length screw may be used in the remaining peripheral screw holes. Both locking or nonlocking screws may be used interchangeably in the remaining holes.
28. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institution’s policy.
29. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.
30. A titanium glenosphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy.

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Virtual Implant Positioning System™ (VIP™ System)

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Indications

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The VIP web portal is intended for use as a software interface and for transferring imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options generated in the OrthoVis desktop software by trained Arthrex technicians. The VIP web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ II and Univers Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ Modular Glenoid System (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines.

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Contraindications

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1. The VIP web portal is not to be used with any shoulder replacement system, or component, other than the total shoulder systems and components identified in the Indications for Use.
2. The VIP web portal and/or VIP system is indicated for use with specific total shoulder systems, listed in the Indications for Use. The contraindications associated with those systems remain unaltered, as described in each implant system’s labeling (with or without using the VIP web portal).
3. The VIP web portal is not indicated for use in shoulder hemiarthroplasty.
4. An unapproved preoperative plan is not to be used for clinical purposes.

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Warnings

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1. Do not use the approved preoperative plan on anyone other than the patient indicated on the approved preoperative plan or in the web portal.
2. The surgeon performing the surgery must be the user responsible for approving the preoperative plan.
3. Do not use the approved preoperative plan after its expiration date (6 months after the CT scan).
4. The VIP preoperative planning system web portal is indicated for use with specific total shoulder systems. The warnings associated with those systems remain unaltered, as described in each implant system’s labeling (with or without using the VIP web portal).
5. Use of the web portal or OrthoVis is not a guarantee of improved accuracy or results as the approved preoperative plan is for visual reference only.
6. Do not use an unapproved preoperative plan (web session or OrthoVis session) for clinical purposes.
7. Due to resolution variation across devices, the images displayed on the web portal are not intended for diagnostic purposes and are for orthopedic surgical planning only. A persistent on-screen message displays this information on the web portal viewer.