BIOMET FIXED CRUCIATE TIBIAL PLATE
Received Jul 10, 2019
Report 0001825034-2019-02906 · MDR key 8775260
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
141236
Lot number
J3672109
Product problems
- Loss of or Failure to Bond
- Unstable
- Loss of or Failure to Bond
- Unstable
Patient
Not reported
- Muscle Weakness/Atrophy
- Pain
- Swelling
- Muscle Weakness/Atrophy
- Pain
- Swelling
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #: (B)(4). MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-04614, 0001825034-2019-04615. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EVENT DATE - UNKNOWN MONTH AND DAY IN 2018. ADDITIONAL INFORMATION RECEIVED, DOES NOT CHANGE THE PREVIOUSLY REPORTED ROOT CAUSE.
Description of Event or Problem
IT WAS FURTHER REPORTED THE PATIENT'S ALLEGATIONS OCCURRED APPROXIMATELY ONE YEAR POST-IMPLANTATION.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCT: VANGUARD CR FEMORAL CATALOG # 183010 LOT # J3906939. PALACOS BONE CEMENT CATALOG # 00111314001 LOT # 85174547 QTY: 2. SERIES A PAT STD 34 3 PEG CATALOG # 184766 LOT # 128320. VNGD CR TIB BRG 12X79/83 CATALOG # 183462 LOT # 520540. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. 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: 0001825034-2019-02905. REMAINS IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PAIN, INSTABILITY, CLUNKING, SWELLING, AND LOOSENING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. HOWEVER, THE PATIENT IS DOING PHYSICAL THERAPY TO RESOLVE THE ADVERSE EVENTS. PATIENT'S MEDICAL RECORDS INDICATE THAT PATIENT HAS ATROPHY/WEAKNESS IN THE RIGHT LEG, BUTTOCKS, THIGH AND CALF. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.