BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2935405 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-02034
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    February 7, 2011
    Report Date
    August 22, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DISCOMFORT, SORENESS AND SWELLING; SENSATION OF SLIPPING AND GRINDING WHICH NEGATIVELY AFFECT ABILITY TO WALK, MOVE OR SLEEP, RESULTING IN A LIMP AND USE OF A CANE; DISCOLORATION OF LEG AND ELEVATED CHROMIUM AND COBALT LEVELS AFTER ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40476 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2348496

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention