BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 1943616 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00676
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE LINER DISENGAGED FROM THE CUP. THE SURGEON REPLACED IT WITH A DELTA CERAMIC HEAD AND A COMPETITOR'S LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP METAL-METAL LINER KWA ENCORE MEDICAL, L.P. 255252

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention (B)(4), LOT# 53836979