BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2772282 · Received October 4, 2012

    Report

    Report Number
    1818910-2012-22432
    Event Type
    Injury
    Date Received
    October 4, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2012: PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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 PAPERS ALLEGE: PATIENT HAS SUFFERED SEVERE PAIN, CRUNCHING OR POPPING NOISES IN HIP REGION, DIFFICULTY STANDING OR WALKING, HIP FRACTURES OR DISLOCATIONS, FATIGUE, TISSUE INFLAMMATION, INFECTION, NECROSIS AND METALLOSIS. IT IS UNKNOWN WHETHER OR NOT PATIENT HAS BEEN REVISED. UPDATE: (B)(6) 2012 - SALES REP REPORTED PATIENT WAS REVISED DUE TO PAIN ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2297152

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention