REGENEREX PATELLA 34MM
Report
- Report Number
- 0001825034-2019-00182
- Event Type
- Injury
- Date Received
- January 16, 2019
- Date of Event
- August 12, 2020
- Report Date
- October 29, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- K171054
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS NOT RETURNED BY THE HOSPITAL. 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. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION OPERATIVE NOTES STATE THAT THE PATELLA WAS FOUND TO BE LOOSE WITH LYSIS OF THE PEGS. ONE OF THE THREE PEGS HAD INTEGRATED AND THE OTHER HAD SHEARED OFF. ALL LOOSE BONEY AND METAL DEBRIS WAS REMOVED. FEMORAL AND TIBIA WERE WELL FIXED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE WAS DETERMINED TO BE A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF REGENEREX PATELLA FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. 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.
(B)(4). THIS COMPLAINT CANNOT BE CONFIRMED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF DEVICE HISTORY RECORDS FOUND NO DEVIATIONS / ANOMALIES IDENTIFIED. PRIMARY OPERATIVE NOTES INDICATE NO INTRAOPERATIVE COMPLICATIONS. THE 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 PATIENT UNDERWENT A RIGHT KNEE REVISION FOUR YEARS POST-IMPLANTATION DUE TO FRACTURE AND LOOSENING OF THE PATELLA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEMORAL RT 70 ITEM # 183052 LOT # 923440, MODULAR FINNED STEM ITEM # 141314 LOT # 74670, REGENEREX TIBIAL TRAY ITEM # 141275 LOT # 904560. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2019-00181, 0001825034-2019-00183, 0001825034-2019-00184. 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 A PATIENT UNDERWENT INITIAL RIGHT KNEE PROCEDURE, SUBSEQUENTLY THE PATIENT IS EXPERIENCING LOOSENING HOWEVER; REVISION IS NOT SCHEDULED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48041 | REGENEREX PATELLA 34MM | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | 684970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |