BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2113353 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08897
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED: CORRECTION/REMOVAL REPORTING NUMBER. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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)(6) 2011: PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) PRESENT, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJUR(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: CONSTANT PAIN, INABILITY TO LEAD A NORMAL LIFE, POSSIBLE COBALT AND NICKEL POISONING; AND POSSIBLE REVISION SURGERY, NUMEROUS DOCTOR VISITS, AND UNABLE TO PERFORM LABOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA Y28H51000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention