G7 STR MODULAR SHELL INSERTER
Report
- Report Number
- 0001825034-2022-02115
- Event Type
- Malfunction
- Date Received
- September 13, 2022
- Date of Event
- August 30, 2022
- Report Date
- April 21, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PBI
- UDI-DI
- 00887868462498
- PMA / PMN Number
- K121874
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). REPORT SOURCE: FOREIGN: SWITZERLAND. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS, 0001825034-2022-02114, 0001825034-2022-02116.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G3; H2; H4; H6 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. ONE G7 BALL HEX DRVR FOR INSR HNDL ITEM# 010002736 LOT# ZB7037336, ONE G7 STR MODULAR SHELL INSERTER ITEM# 110003451 LOT# 541700, AND ONE G7 OSSEOTI 3 HOLE SHELL 50MM D ITEM# 110010243 LOT#7240122 WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE IS SCUFFING ON THE DRIVER HANDLE ALONG WITH WEAR LINES. THE TIP OF THE DEVICE HAD FRACTURED. THE INSERTER SHOWED INDENTATION NEAR THE RUBBER HANDLE AND TO THE STRIKE PLATE. THE INSERTER IS STUCK INSIDE OF THE SHELL AND COULD NOT BE REMOVED. THE SHELL HAD NO VISIBLE DAMAGE. THE THREADS OF THE SHELL AND INSERTER COULD NOT BE CHECKED DUE TO NOT BEING ABLE TO SEPARATE THEM. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, G6, H2, H3, H6, H10 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SHELL REMAINS ASSEMBLED WITH THE INSERTER. THE TIP OF THE HEX DRIVER IS FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
IT WAS REPORTED AFTER IMPLANTATION AND WHEN LOOSENING THE SOCKET, THE BALL HEX DRIVER BROKE OFF. THE SHELL COULD NO LONGER BE DETACHED AFTER REPEATED ATTEMPTS FROM THE INSERT HANDLE AND HAD TO BE REMOVED TOGETHER WITH THE PAN. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2392471 | G7 STR MODULAR SHELL INSERTER | INSTRUMENT, HIP | PBI | ZIMMER BIOMET, INC. | N/A | 541700 | 00887868462498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | CAT#: 010002736 HEX DRIVER LOT#: ZB7037336.| CAT#: 110010243 G7 SHELL LOT#: 7240122. |