BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CRUCIATE TIBIAL TRAY 87MM

    MDR report key: 21675718 · Received March 24, 2025

    Report

    Report Number
    0001825034-2025-00782
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    August 17, 2021
    Report Date
    August 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - VANGUARD POSTERIOR STABILIZED FEMORAL COMPONENT RIGHT 80MM CATALOG #: 183116 LOT #: 141360, VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 87/91MM CATALOG #: 183780 LOT #: 056750, SERIES A STANDARD 3 PEG PATELLA 31MM CATALOG #: 184764 LOT #: 017550 THE COMPLAINANT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: MEDICAL RECORDS PROVIDED CONFIRMED THE REPORTED EVENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, SWELLING, LIMPING AND TIBIAL LOOSENING APPROXIMATELY NINE (9) YEARS POST-OPERATIVELY. REVISION OPERATIVE NOTES NOTED THE FEMORAL COMPONENT WAS REMOVED EASILY WITH MINIMAL CEMENT OSSEOINTEGRATION AND THE TIBIAL TRAY WAS GROSSLY LOOSE WITH A MODERATE AMOUNT OF BONE LOSS. THERE WAS ALSO SIGNIFICANT STAINING THROUGHOUT THE SOFT TISSUE. THE PATELLAR COMPONENT WAS STABLE AND NOT REMOVED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768412 BIOMET CRUCIATE TIBIAL TRAY 87MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J2835994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE