BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 44

    MDR report key: 2832246 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-24745
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    April 1, 2009
    Report Date
    August 17, 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
    FL, 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).

    Additional Manufacturer Narrative · 1

    PLEASE DISREGARD THE INITIAL MDR SENT FOR THIS PRODUCT, AS IT WAS REPORTED UNDER MFR REPORT # 1818910-2012-24747. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED INJURY TO THE BODY AND EXTREMITIES, PAIN, PERMANENT INJURY TO THE BODY AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 44 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 1960340

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention