BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 67MM

    MDR report key: 16036656 · Received December 22, 2022

    Report

    Report Number
    0001825034-2022-02826
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    August 30, 2022
    Report Date
    December 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 183006 - VANGUARD CR ILOK FEM-RT 62.5 - 43380. 183522 - VNGD CR LIP TIB BRG 12X63/67 - 70470. 184764 - SERIES A PAT STD 31 3 PEG - 964590. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 AN INITIAL RIGHT TKA AND WAS SUBSEQUENTLY REVISED DUE TO TIBIAL SUBSIDENCE APPROXIMATELY 9 YEARS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2826819 BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R