BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERAMOS HIP

    MDR report key: 1914464 · Received November 23, 2010

    Report

    Report Number
    1644408-2010-00634
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K955563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT'S IMPLANT KEPT DISLOCATING, THE SURGEON IMPLANTED A CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERAMOS HIP FEMORAL CERAMIC HEAD LPH ENCORE MEDICAL, L.P. 285342K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4), LOT 53989291| (B)(4), LOT 53995541