COMP RVS CNTRL 6.5X35MM ST/RST
Report
- Report Number
- 0001825034-2025-00725
- Event Type
- Injury
- Date Received
- March 14, 2025
- Report Date
- July 28, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00880304677098
- PMA / PMN Number
- K193373
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: AUSTRALIA. D10 NARRATIVE: ITEM:EP-010000589. LOT: 675430. ITEM NUMBER: COMP RVRS 25MM BSPLT HA+ADPTR. ITEM:EP-115395. LOT: 093300. ITEM NUMBER: E1 44-36 RTNV +3 HMRL BRG. ITEM:115310. LOT: 045290. ITEM NUMBER: COMP RVRS SHLDR GLNSP STD 36MM. ITEM:115370. LOT: 795950. ITEM NUMBER: COMP RVS TRAY CO 44MM. ITEM:113629. LOT: 491120. ITEM NUMBER: COMP PRIMARY STEM. 9MM MINI. ITEM:180553. LOT: 420680. ITEM NUMBER: COMP LK SCR 3.5HEX. 4.75X30 ST. ITEM: 180553. LOT: 420680. ITEM NUMBER: COMP LK SCR 3.5HEX. 4.75X30 ST. ITEM:180554. LOT: 330090. ITEM NUMBER: COMP LK SCR 3.5HEX 4.75X35 ST. ITEM:180554. LOT: 146450. ITEM NUMBER: COMP LK SCR 3.5HEX 4.75X35 ST. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11 H10: RELATED REPORT #'S: 0001825034-2025-00722, 0001825034-2025-00724, 0001825034-2025-00723, 0001825034-2025-00726, 0001825034-2025-00727, 0001825034-2025-00728, 0001825034-2025-00730, 0001825034-2025-00729, 0001825034-2025-00731, AND 0001825034-2025-00995. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NURSING TIMELINE REVIEWED INFORMATION PROVIDED AND IDENTIFIED THE FOLLOWING: PMI REQUEST RECEIVED, PENDING REVISION DUE TO UNKNOWN REASON. THE REP RESPONSE STATES THAT THE PATIENT WAS BOOKED FOR A REVISION APPROXIMATELY 2 YEARS AGO (UNKNOWN IF THIS IS REFERRING TO KNEE OR SHOULDER PROSTHESIS). MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BOTH BASEPLATES/TAPER ADAPTERS ARE A PART OF A BET RECALL. THE REASON FOR THIS REVISION IS UNKNOWN, AND THEREFORE, CANNOT BE DETERMINED IF THE REPORTED EVENT IS RELATED TO THE DEVIATIONS/RECALL. THE REPORTED EVENT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED, WHICH WAS REVISED 4 DAYS LATER DUE TO DISSOCIATION. SUBSEQUENTLY, THE PATIENT IS NOW BEING CONSIDERED FOR A PATIENT MATCHED IMPLANT DUE TO UNKNOWN REASONS.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562848 | COMP RVS CNTRL 6.5X35MM ST/RST | SHOULDER PROSTHESIS, REVERSE CONFIGURATION | PHX | ZIMMER BIOMET, INC. | 478340 | 00880304677098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Other | SEE H11 NARRATIVE |