BIOMET CC CRUCIATE TRAY
Report
- Report Number
- 0001825034-2020-00801
- Event Type
- Injury
- Date Received
- February 21, 2020
- Date of Event
- July 23, 2019
- Report Date
- May 12, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- MBH
- PMA / PMN Number
- K142933
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
MEDICAL PRODUCT: BIOMET CC CRUCIATE TRAY 67MM CATALOG # 141232 LOT # 061960 VNGD PS TIB BRG 14X63/67MM CATALOG # 183624 LOT # 613560 SERIES A PAT THN 28 3 PEG CATALOG # 184782 LOT # 477800 OPTIVAC TOTAL HIP KIT CATALOG # 418000 LOT # 0000823738 COBALT MV BONE CEMENT 40GM B CATALOG # 402438 LOT # 863050.
CONCOMITANT MEDICAL PRODUCTS: COBALT MV BONE CEMENT 40GM B CATALOG # 402438 LOT # 863050. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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. MULTIPLE MDR: 0001825034 - 2020 - 01675.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. REVISION OPERATIVE NOTES INDICATES THAT TIBIAL AND FEMORAL COMPONENTS WERE EASILY REMOVED AND INITIAL PATELLAR COMPONENT REMAINED INTACT. ADDITIONAL INFORMATION DOES NOT AFFECT THE ROOT CAUSE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. DURING THE REVISION, THE TIBIAL AND FEMORAL COMPONENTS WERE EASILY REMOVED AND REPLACED WITH COMPETITOR PRODUCT.
(B)(4). CONCOMITANT MEDICAL PRODUCT: VAN PS OPEN INTL FEM-RT 62.5 CATALOG # 183106 LOT # UNKNOWN; VNGD PS TIB BRG 14X63/67MM CATALOG # 183624 LOT # UNKNOWN; SERIES A PAT THN 28 3 PEG CATALOG # 184782 LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-00800.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL PROSTHESIS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203628 | BIOMET CC CRUCIATE TRAY | PROSTHESIS, KNEE | MBH | ZIMMER BIOMET, INC. | N/A | J3118728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |