BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP SYSTEM

    MDR report key: 1053025 · Received May 27, 2008

    Report

    Report Number
    1644408-2008-00165
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE INVESTIGATION IS LIMITED IN SCOPE SINCE NONE OF THE PRODUCTS FROM THE REVISION SURGERY WERE RETURNED TO ENCORE FOR EXAMINATION. IF THE PRODUCTS CAN BE LOCATED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED. THERE WAS NO INFO IN THE PRODUCT COMPLAINT REPORT THAT SHOWED MATERIAL, DESIGN, OR MFG PROBLEMS WITH THE HIP SYSTEM IMPLANTS. A REVIEW OF THE MFG RECORDS FOUND ONE DISCREPANCY, NOT RELATED TO THE EVENT THAT LED TO THIS PRODUCT COMPLAINT. NO CONTAINMENT OF INVENTORY IS RECOMMENDED AS THERE ARE NO INDICATIONS THAT THE IMPLANT DESIGN OR MATERIALS WERE RELATED TO THE PTS REVISION. ENCORE CONSIDERS THIS THE FINAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY - PT REPORTED A "POP" IN HIS HIP ABOUT FOUR YRS AFTER THE ORIGINAL SURGERY. AFTER THAT INCIDENT THE HIP DISLOCATED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP SYSTEM LINER, FMP KWB ENCORE MEDICAL, L.P. 693601

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 400-01-290/738731