FEMORAL STEM BEADED FULLCOAT 12/14
Report
- Report Number
- 0001822565-2022-01840
- Event Type
- Injury
- Date Received
- June 21, 2022
- Date of Event
- October 22, 2021
- Report Date
- September 19, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 00889024136502
- PMA / PMN Number
- K973714
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CATALOG NUMBER: 00784301226 LOT NUMBER: 60189250 BRAND NAME: VERSYS BEADED FULLCOAT STEM. CATALOG NUMBER: UNKNOWN LOT NUMBER: 6022914 BRAND NAME: UNKNOWN. UNKNOWN TM SHELL. UNKNOWN LONGEVITY LINER. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. PROPOSED COMPONENT CODE: MECHANICAL (G04)-STEM. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. REVISION NOTES WERE NOT PROVIDED, HOWEVER PATHOLOGY NOTES CONFIRMED THE STEM FRACTURED. ALL PRODUCTS WERE EXPLANTED, AND ZIMMER PRODUCTS WERE PLACED IN CONJUNCTION WITH COMPETITOR PRODUCT. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: G3; H2. ADDITIONAL MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IT WAS REPORTED THERE WAS AN INITIAL THA. A REVISION OCCURRED ON DUE TO PAIN AND THE INABILITY TO AMBULATE. THE STEM WAS FOUND TO BE BROKEN WITH METALLOSIS IN THE JOINT. A DEFINITIVE ROOT CAUSE CANNOT 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 THAT THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE APPROXIMATELY 16 YEARS POST IMPLANTATION. THE STEM, HEAD, SHELL, AND LINER WERE EXCHANGED AND COMPETITOR PRODUCT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED RIGHT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 16 YEARS POST IMPLANTATION DUE TO IMPLANT FRACTURE. DURING THE REVISION METALLOSIS WAS NOTED AND CLEANED THROUGHOUT THE JOINT CAVITY. THE ACETABULAR SHELL WAS FOUND TO BE WELL POSITIONED AND WELL FIXED. THE STEM, HEAD, AND LINER WERE EXCHANGED.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 598149 | FEMORAL STEM BEADED FULLCOAT 12/14 | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 60189250 | 00889024136502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H | SEE H10 NARRATIVE. |