BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET

    MDR report key: 94823 · Received May 28, 1997

    Report

    Report Number
    94823
    Event Type
    Other
    Date Received
    May 28, 1997
    Date of Event
    April 30, 1997
    Report Date
    May 27, 1997
    Manufacturer
    BIOMET
    Product Code
    LPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT FELL, WAITED 3 WKS, CONTACTED SURGEON, WHO TOOK X-RAYS THAT SHOWED FRACTURE LINE VISIBLE ON SUPERIOR MARGIN OF HEAD IN A/P VIEW, MINIMAL DISPLACEMENT. THIS THEN REQUIRED A REVISION SURGERY OF THIS HIP COMPONENT PRODUCT. AT TIME OF SURGERY IT WAS NOTED THAT THERE WERE THREE PRIMARY FRAGMENTS CONTAINED WITHIN THE ACETABULAR LINER. LINER SHOWING OBVIOUS DAMAGE, "FRETTING" NOTED ON TRUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET Implant CERAMIC MODULAR HEAD 28 MM HIP IMPLANT LPF BIOMET NA 224380

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other