BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2210473 · Received August 9, 2011

    Report

    Report Number
    1818910-2011-15311
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 15, 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 Location
    AL, US
    Reporter Occupation
    ATTORNEY

    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 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

    LITIGATION PAPERS ALLEGE PERSISTENT ACHES AND PAINS IN HER RIGHT HIP, TROUBLE SITTING AND GETTING UP THEY HAD TO BUY A LIFT CHAIR, SWELLING IN HER RIGHT LEG, NEEDS A WALKER TO WALK, LOWER BACK PAIN, FEMUR FRACTURE, SENSATION THAT HIP IS NOT "IN PLACE", AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2646174

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention