BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 3161861 · Received June 6, 2013

    Report

    Report Number
    1644408-2013-00312
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWL
    PMA / PMN Number
    K973614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 2.1 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 BY THE HOSPITAL 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: NCMR #8695 INVOLVED TWO PARTS THAT WERE SCRAPPED DUE TO OVERSIZED FEATURES. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE SECOND COMPLAINT FOR THIS PART NUMBER: ONE DUE TO DISLOCATION AND ONE DUE TO TRAUMA. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION COULD NOT BE DETERMINED WITH CONFIDENCE. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS; LOOSE JOINT FROM SOFT TISSUES AND PATIENT ACTIVITY. THERE WERE NO REPORTS OF ANY CIRCUMSTANCES THAT MAY HAVE LED TO THE PATIENT'S DISLOCATION. 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'S HIP DISLOCATED, AND THE SURGEON REMOVED THE UNIPOLAR AND SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250165 FOUNDATION HIP UNIPOLAR HEAD KWL ENCORE MEDICAL, L.P. 53771902

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 411-00-700: LOT, 53837056