BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUP 54

    MDR report key: 2981529 · Received February 27, 2013

    Report

    Report Number
    1818910-2013-02718
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (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.

    Additional Manufacturer Narrative · 1

    UPDATE (B)(4) 2013 - ASR/SUPPLEMENTAL INFORMATION RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PERMANENT INJURIES DUE TO SEVERE METAL POISONING AND METALLOSIS, METAL DEBRIS WITHIN THE JOINT AND PREMATURE REVISION OF THE ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83696 ASR ACETABULAR CUP 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2611266

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention