BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2113091 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08580
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    April 22, 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

    PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. DEPUY STILL 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

    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. WWCAPA (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

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: SINCE SURGICAL IMPLANTATION OF THE ASR XL ACETABULAR SYSTEMS, PATIENT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING. PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY AND CONSCIOUS PAIN AND SUFFERING. PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERY ON HIS RIGHT HIP ON (B)(6) 2010 AND IS SCHEDULED [FOR REVISION SURGERY] ON HIS LEFT HIP ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2264790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention