BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2844955 · Received November 14, 2012

    Report

    Report Number
    1644408-2012-00603
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWL
    PMA / PMN Number
    K973614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A FRACTURED FEMUR AFTER TWO WEEKS 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 NOT RETURNED TO (B)(4) SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT DUE TO A VISUAL NONCONFORMANCE. ONE OF SIX PIECES WAS DISPOSITIONED AS SCRAP. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE THIRD COMPLAINT FOR THIS PART NUMBER: ONE DUE TO DISLOCATION AND ONE FOR A TIGHT JOINT. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE FRACTURED FEMUR WAS MOST LIKELY DUE TO THE PATIENT FALLING. 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 - THE PT FELL AND SUSTAINED A FRACTURE OF THE FEMUR. THE SURGEON IMPLANTED A UNIPOLAR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP UNIPOLAR HEAD KWL ENCORE MEDICAL, L.P. A1000000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 411-00-035, LOT 903B1053| 425-01-012, LOT 066C1005