COMPREHENSIVE REVERSE SHOULDER SMALL AUGMENTED BASEPLATE WITH MINI TAPER ADAPTER
Report
- Report Number
- 0001825034-2025-01784
- Event Type
- Injury
- Date Received
- June 18, 2025
- Date of Event
- May 27, 2025
- Report Date
- November 26, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00880304993235
- PMA / PMN Number
- K172502
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: . D10: ITEM# 115395; LOT# 66070571 ITEM# 180551; LOT# 66257924 ITEM# 180551; LOT# 65918827 ITEM# 180550; LOT# 66244332 ITEM# 180550; LOT# 66212788 ITEM# 115310; LOT# J7431052 ITEM# 110031405; LOT# 66100903 ITEM# 110031424 66064905 ITEM# 118001 J7888400 ITEM# 113057 J7405265 IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). D10: ITEM# 115395; LOT# 66070571, ITEM# 118001; LOT# J7888400, ITEM# 113057; LOT# J7405265, ITEM# 180551; LOT# 66257924, ITEM# 180551; LOT# 65918827, ITEM# 180550; LOT# 66244332, ITEM# 180550; LOT# 66212788, ITEM# 115310; LOT# J7431052, ITEM# 110031405; LOT# 66100903, ITEM# 110031424; LOT# 66064905. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H10 CORRECTION TO H10 ENTRIES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVERSE TOTAL SHOULDER ARTHROPLASTY WITH LOOSENING OF THE GLENOID COMPONENT. CLOSE APPROXIMATION OF THE INFEROMEDIAL PORTION OF THE HUMERAL COMPONENT AND METAGLENE COULD RESULT IN CONTACT OF THE COMPONENTS DURING ADDUCTION, RESULTING IN THE DESCRIBED FRANK METALLOSIS AT THE TIME OF SURGERY. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS POST-IMPLANTATION DUE TO A BROKEN CENTRAL SCREW AND A LOOSE GLENOID COMPONENT. SUBSEQUENTLY, THE PATIENT WAS CONVERTED FROM A REVERSE TO A HEMI ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1684732 | COMPREHENSIVE REVERSE SHOULDER SMALL AUGMENTED BASEPLATE WITH MINI TAPER ADAPTER | SHOULDER PROSTHESIS, REVERSE CONFIGURATION | PHX | ZIMMER BIOMET, INC. | NI | 66125641 | 00880304993235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H | SEE NARRATIVE IN H11 |