BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2172612 · Received July 19, 2011

    Report

    Report Number
    1818910-2011-13438
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 ACTION. REF (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT CONTACTED BROADSPIRE TO INITIATE CLAIM. PT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME. UPDATE: (B)(6) 2011 - THE REVISION WAS REPORTED BY THE SALES REP. THE BILATERAL PT WAS REVISED TO ADDRESS PAIN AND SLIGHTLY ELEVATED METAL ION LEVELS. THE CUP ON THE LEFT SIDE SHOWED LESS THAN 15% INGROWTH WITH BLACK DEBRIS IN THE TISSUE. THE RIGHT SIDE REVEALED MORE GRAY METALYSIS/SYNOVIAL MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2007576

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention