BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2852033 · Received November 30, 2012

    Report

    Report Number
    1818910-2012-24221
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    August 23, 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
    IL, 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SOMETIME AFTER IMPLANTATION, THE PATIENT WAS ADVISED THAT HIS IMPLANT WAS FAILING AND THAT HE HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HIS BLOOD. ADDITIONALLY, THE LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES OF A PERMANENT NATURE; ENDURED PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HIS NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 ACETABULAR SHELL KWA DEPUY INTERNATIONAL 2538504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other