BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2260213 · Received September 22, 2011

    Report

    Report Number
    1818910-2011-18911
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    March 21, 2011
    Report Date
    August 25, 2011
    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
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2653727

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention