BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2141299 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10869
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    October 10, 2013
    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
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    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

    **UPDATE**(B)(4) 2013 - SALES REP HAS REPORTED REVISION SURGERY. NO REASON FOR REVISION HAS BEEN GIVEN.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS LEFT SIDE. PT HAS SUFFERED PHYSICAL AND MENTAL PAIN, COMPLICATIONS, AND ALLEGEDLY A REVISION SURGERY. HE SUSTAINED ECONOMIC LOSSES, LOSING HIS WAGES AND FRINGE BENEFITS, AND INCURRING MEDICAL AND PHARMACEUTICAL EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR SHELL KWA DEPUY INTERNATIONAL, LTD. NA 2610291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention