COMP REV MINI TRAY STD COCR +0 OFFSET
Report
- Report Number
- 0001822565-2025-02257
- Event Type
- Injury
- Date Received
- July 1, 2025
- Date of Event
- August 8, 2024
- Report Date
- November 20, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00887868231315
- PMA / PMN Number
- K181611
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: MEDICAL RECORDS: ITEM#: 110031418, CR PROLONG 36MM BRNG STD; LOT#: 66259457 ITEM#: 113632, COMP PRIMARY STEM 12MM MINI; LOT#: 66335967 ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 625110 ITEM#: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST; LOT#: 66008695 ITEM#: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST; LOT#: 66008695 ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 66665365 ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 66450519 H3: 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B4, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RADIOGRAPH NOTES FROM 5 AUG 2024 INDICATED MECHANICAL FAILURE OF THE GLENOSPHERE COMPONENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: GLENOSPHERE TAPER HAS DISASSOCIATED FROM THE BASEPLATE. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A4; B4; B5; B7; D2; G2; G3; G6; H1; H2; H6. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED UNKNOWN COMPLICATION WITH NO KNOWN INTERVENTION TO DATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. NO PROBLEM FOUND. IT WAS IDENTIFIED THAT THE PATIENT UNDERWENT A REVISION FOR DISASSOCIATION BETWEEN THE TAPER ADAPTOR AND BASEPLATE. THEREFORE, THE TRAY AND BEARING ARE UNRELATED TO THE REPORTED EVENT, AND THE DISASSOCIATION IS BEING INVESTIGATED ON THE LINKED COMPLAINT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AND A HALF AFTER THEIR INTIAL SURGERY DUE TO A MECHANICAL FAILURE OF THE GLENOSPHERE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1193601 | COMP REV MINI TRAY STD COCR +0 OFFSET | SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES | PHX | ZIMMER BIOMET, INC. | 66653185 | 00887868231315 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Hospitalization| R| O | SEE H11 NARRATIVE. |