BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVE 11/13 +0

    MDR report key: 3233080 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21516
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK004627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. REF. (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

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE: (B)(6) 2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: MEDICAL RECORDS RECEIVED (B)(6) 2013. REVISION OPERATIVE REPORT INDICATES INCREASED COBALT AND CHROME LEVELS, CYST FORMATION, YELLOWISH FLUID, HARD PSEUDOTUMOR, SCRATCHES ON THE FEMORAL HEAD AND ACETABULAR COMPONENT, SIGNIFICANT EVIDENCE OF GALVANIC ROTATION AND GALVANIC CORROSION. ADAPTER SLEEVE, STEM, AND STEM SLEEVE ADDED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334810 ADAPTER SLEEVE 11/13 +0 ADAPTER SLEEVE KWA DEPUY INTL., LTD. - 8010379 2191267

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR