EQUINOXE PRIMARY SHOULDER COMPONENTS
Received Sep 30, 2025 · Event occurred Jan 26, 2023
Report 1038671-2025-03014 · MDR key 23184157
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No
Manufacturer
Exactech, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
71 YR · Male
- Pain
- Muscle/Tendon Damage
- Pain
- Muscle/Tendon Damage
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A SUBSCAPULARIS TEAR, PAIN AND DECREASED FUNCTION. THE SURGEON RECOMMENDED REVISION SURGERY, BUT THE PATIENT DECLINED IN ORDER TO ADDRESS THEIR KNEE WHICH THEY CONSIDERED MORE BOTHERSOME AT THAT TIME. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
D10: 300-60-02 - STEMLESS HUMERAL COMP LASER CAGE, SIZE 2: (B)(6), 310-62-50 - STEMLESS HUMERAL HEAD 50MM X 16MM X BETA: (B)(6), 314-24-34 - LASER CAGE GLENOID L, 8 POST AUG, RIGHT: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, D THE REASON FOR THE CONSIDERATION OF SHOULDER SURGICAL REVISION REPORTED IS LIKELY DUE TO ROTATOR CUFF FAILURE AS REPORTED. CONTRIBUTIONS FROM PATIENT-RELATED ISSUES, SOFT TISSUE TENSIONING, AND/OR COMPONENT POSITIONING OR SIZING ISSUES TO THE REPORTED EVENT CANNOT BE DETERMINED FROM THE REPORTED INFORMATION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.