BEUDAMED
    FDA Adverse Event Summary report: N

    FMP/FOUNDATION HIP

    MDR report key: 3000308 · Received March 12, 2013

    Report

    Report Number
    1644408-2013-00144
    Date Received
    March 12, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974093
    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 TO REMEDY PAIN THE PATIENT WAS SUFFERING FROM AFTER 9.4 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 NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH PART NUMBER (B)(4) FOR OVERSIZED FEATURES ON THREE PARTS; (B)(4). A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THIS PART NUMBER. THE ROOT CAUSE FOR THE PAIN WAS MOST LIKELY DUE TO WEAR. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT EXPERIENCED PAIN DUE TO WEAR OF THE ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102664 FMP/FOUNDATION HIP ACETABULAR LINER MOLDED NEUTRAL LPH ENCORE MEDICAL, L.P. 691711

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 497-28-000, LOT 932961