EQUINOXE SHOULDER COMPONENT
Received Jun 4, 2025 · Event occurred Feb 15, 2024
Report 1038671-2025-02236 · MDR key 22145171
Device
Generic name
Prosthesis, Shoulder, Constrained, Metal/metal Or Metal/polymer Cemented
Manufacturer
Exactech, Inc.Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Unknown
- Inflammation
- Pain
- Loss of Range of Motion
- Discomfort
- Osteolysis
- Muscle/Tendon Damage
- Swelling/ Edema
- Inflammation
- Pain
- Loss of Range of Motion
- Discomfort
- Osteolysis
- Muscle/Tendon Damage
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-05047. THE REASON FOR THE REVISION REPORTED IN THIS EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOOSENING, LOSS OF RANGE OF MOTION, OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED TO EXACTECH FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR CLINICAL INFORMATION WERE PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 78 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT AND INFLAMMATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.