BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP SYSTEM

    MDR report key: 1053026 · Received May 27, 2008

    Report

    Report Number
    1644408-2008-00167
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PARTS ARE TO BE RETURNED. WHEN PARTS ARE RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    LINER WAS FOUND DISLOCATED OUT OF THE SHELL IN 2008 FOR A THR CASE CONDUCTED IN 2007. THERE WAS A SIMILAR CASE IN SEPT. 2007. THE SURGEON REQUESTS THAT THE MFR CLARIFY WHETHER THE PROBLEMS COULD BE ATTRIBUTED TO THE DESIGN OF THE SHELL AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP SYSTEM LINER, METAL ON METAL KWB ENCORE MEDICAL, L.P. 283912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 010-55-02/53838686A X2| 430-06-048/267432| 010-55-025/53793614B X2| 497-28-000/53869069