BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3050583 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-04818
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    May 3, 2013
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO CATALOG AND LOT #. UPDATE 5/3/2013 - PPD RECEIVED. PART/LOT HAS BEEN UPDATED. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN IN LEFT HIP AND GROIN; PAIN WHEN WALKING; INABILITY TO ENGAGE IN RECREATIONAL ACTIVITIES AND ACTIVITIES OF DAILY LIVING; EXCESSIVE LEVELS OF CHROMIUM AND COBALT; AND OTHER SIGNS AND SYMPTOMS DUE TO ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148940 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2199317

    Patients

    Seq Age Sex Outcome Treatment
    1 Other