BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY

    MDR report key: 7371954 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02222
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - VANGUARD CR LIP TIBIAL BEARING # 183540 LOT # 416260; VANGUARD CR ILOK FEMUR-LEFT # 183032 LOT # 378110; BIOMET ARCOM AP PAT W/WIRE # 11-150828 LOT # 96652. THE COMPLAINT WAS CONFIRMED. PHOTOGRAPHIC REVIEW OF THE TIBIAL PLATE SHOW THAT IT IS FRACTURED AT THE POSTERIOR MEDIAL CORNER AND PHOTOGRAPH OF THE BEARING SHOWS EXCESSIVE WEAR ON THE SURFACE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN, LOOSENING AND COMPLETE FRACTURE OF THE POSTERIOMEDIAL CORNER OF THE TIBIAL TRAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212114 BIOMET CC I-BEAM TRAY PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 206810

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R