BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 3750348 · Received February 28, 2014

    Report

    Report Number
    3750348
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 27, 2014
    Manufacturer
    BIOMET
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD LEFT TOTAL HIP ARTHROPLASTY (THA) ON (B)(6) 2011. PREVIOUSLY, PT HAD RIGHT THA AT (B)(6). BIOMET DEVICES WERE USED. PT REQUIRED LEFT THA EXPLANTATION/REVISION OF ACETABULUM AND FEMORAL HEAD DUE TO LOOSENING OF THE ACETABULAR COMPONENT, REASONABLY DUE TO METALLIC DEBRIS. DEVICES THAT WERE EXPLANTED ARE: CUP (38MM M2A) AND HEAD (28MM M2A). DESCRIPTIONS PROVIDED BY BIOMET REPRESENTATIVE. INTRAOPERATIVE REPORT FROM (B)(6) NOTES THE HEAD TO BE CATALOG # 11-173660 (LOT # 814260) AND THE ACETABULAR CUP TO BE CATALOG # 15-105054 (LOT # 727980). UPON REQUEST OF PT, THE EXPLANTED COMPONENTS WERE SENT TO THE PT'S ATTORNEY. COMPONENTS ARE NO LONGER AVAILABLE TO THE FACILITY. BIOMET REPRESENTATIVE MARK BUBLICK HAS RECEIVED A COPY OF THIS REPORT ON BEHALF OF BIOMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123560 BIOMET ACETABULAR CUP KWA BIOMET 727980

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention