STEMLESS SHOULDER COMPONENTS
Received May 29, 2025 · Event occurred Jul 6, 2023
Report 1038671-2025-02189 · MDR key 22105710
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
75 YR · Male
- Medical device site infection
- Medical device site infection
Narrative
Additional Manufacturer Narrative
D6A: IMPLANTED DATE UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-01760. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS FRACTURE, MIGRATION, AND WEAR OF THE CAGED GLENOID. THE CAUSE OF THESE FAILURES CANNOT BE CONFIRMED BUT MAY BE THE RESULT OF IMPROPER INITIAL SEATING OF THE GLENOID, OFF-AXIS DRILLING OF THE PERIPHERAL PEGS, AND/OR OFF-LABEL NON-CEMENTED USAGE RESULTING IN A ROCKING HORSE EFFECT. THE REPORTED INFECTION COULD HAVE BEEN AN ADDITIONAL CONTRIBUTING FACTOR TO THESE FAILURES; HOWEVER, THE SERIES OF EVENTS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INITIAL POST-OPERATIVE RADIOGRAPHS WERE NOT 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
AS REPORTED, THE PATIENT HAD AN INITIAL TSA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO THE POLY AND PERIPHERAL PEGS BECOMING DISASSOCIATED FROM THE CENTRAL CAGE AND SHEARING OFF. OSTEOMYELITIS CAUSED THE IMPLANT TO FAIL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. IMAGES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.