BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2573870 · Received May 4, 2012

    Report

    Report Number
    1644408-2012-00240
    Event Type
    Other
    Date Received
    May 4, 2012
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY- THE PT HAD A TOTAL HIP ARTHROPLASTY PERFORMED IN 2007, BUT RECENTLY FELL AND DEVELOPED AN ACETABULAR HEMATOMA. IN TURN, THE HIP BECAME INFECTED, AND THE INFECTION SPREAD INTO JOINT CAPSULE. AS A RESULT, THE SURGEON PROCEEDED TO REMOVE THE METAL-ON-METAL LINER AND COCR HEAD AND REPLACED THEM WITH A HXL POLY LINER AND COCR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP METAL-ON-METAL LINER- NEUTRAL MP9 LPH ENCORE MEDICAL, L.P. 53812731

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 411-00-035, LOT 53611711| 497-38-000, LOT 53836976