BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 3122616 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00273
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS THE MEDIAL WALL OF THE PATIENT'S ACETABULUM FRACTURING AFTER 35 DAYS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT: (B)(4) SHOWED TEN PARTS WITH MARKING PLACEMENT ERRORS. ALL OF THE PARTS WERE ACCEPTED; THE MARKING WAS LEGIBLE AND WOULD NOT AFFECT THE FUNCTION. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 14TH COMPLAINT FOR THIS PART NUMBER: ONE DUE TO TRAUMA, TWO DUE TO INFECTION, TWO FOR STABILITY/POOR JOINT ISSUES, AND NINE DUE TO DISLOCATION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE ACETABULUM FRACTURE COULD NOT BE DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - METAL WALL OF THE ACETABULUM FRACTURED. REPLACED CUP AND LINER WITH COMPETITOR'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214548 FMP HIP COCR HEAD KWA ENCORE MEDICAL, L.P. 638C1067

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention (B)(4), LOT 53929793| (B)(4), LOT 006A1071| (B)(4), LOT 692F1053| (B)(4), LOT 902B1092| (B)(4), LOT 329C1029