BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 2801530 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-22654
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 4, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED PAIN, WEAKNESS, AND THE IMPLANT GENERATED EXCESSIVE METAL DEBRIS. (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. (B)(6) 2012 - REVISION OPERATIVE REPORT WAS RECEIVED. BROWN FLUID AND CORROSIVE MATERIAL WAS NOTED AFTER THE FEMORAL HEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14 +5 ADAPTER SLEEVE KWA DEPUY INTERNATIONAL 2839202

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR