UNKNOWN TRIAL POST
Report
- Report Number
- 0001825034-2022-00376
- Event Type
- Injury
- Date Received
- February 21, 2022
- Date of Event
- October 16, 2021
- Report Date
- January 11, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MEDICAL PRODUCT: BIOMET CC CRUCIATE TRAY 71MM CATALOG # 141233 LOT # J7030162; VAN PS OPEN INTL FEM-RT 67.5 CATALOG # 183110 LOT # J6638463; BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 172490; VNGD PS+ TIB BRG 12X71/75MM CATALOG # 183742 LOT # 953060; BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 478340. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THERE IS A RECTANGULAR METALLIC FOREIGN BODY WITHIN THE DISTAL FEMUR. 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. NOT RETURNED BY HOSPITAL.
(B)(4). MEDICAL PRODUCT: BIOMET CC CRUCIATE TRAY 71MM CATALOG # 141233 LOT # J7030162; VAN PS OPEN INTL FEM-RT 67.5 CATALOG # 183110 LOT # J6638463; BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 172490; VNGD PS+ TIB BRG 12X71/75MM CATALOG # 183742 LOT # 953060; BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 478340. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THERE IS A RECTANGULAR METALLIC FOREIGN BODY WITHIN THE DISTAL FEMUR. 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. NOT RETURNED BY HOSPITAL.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. D6: DEVICE WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2021.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. ADDITIONAL INFORMATION DOES NOT AFFECT THE ROOT CAUSE. MEDICAL RECORDS REVIEW INDICATES THERE IS NO COMPLICATION DURING INITIAL SURGERY. ON (B)(6) 2021, METALLIC PART WAS IDENTIFIED VIA X-RAY. CT WERE TAKEN AND CONSISTENT WITH CRUCIATE RETAINING POLYETHYLENE TRIAL POST. APPEARS IN THE SPACE BEHIND OF THE POLYETHYLENE POST BETWEEN THE MEDIAL AND LATERAL POSTERIOR FEMORAL CONDYLE. REVISION SURGERY WAS PERFORMED AND THE POST FROM THE PS TRIAL WAS IDENTIFIED IN THE INTERCONDYLAR NOTCH AND REMOVED. NO OTHER COMPLICATION WAS NOTED. 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 PATIENT UNDERWENT A REVISION PROCEDURE FIFTEEN DAYS POST IMPLANTATION DUE TO FOREIGN BODY IN KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIFTEEN DAYS POST IMPLANTATION DUE TO FOREIGN BODY IN KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358778 | UNKNOWN TRIAL POST | INSTRUMENT KNEE | JWH | ZIMMER BIOMET, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H |