BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2863951 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25486
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 15, 2012
    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 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. (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. NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, LOSS OF ENERGY, IMMOBILIZATION, AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES INCREASED RISK OF PREMATURE FAILURE OF THE REPLACEMENT DEVICE AND SUBSEQUENT DEVICES AND OTHER COMPLICATIONS FROM PREMATURE REVISION SURGERY AND DIMINUTION IN QUALITY OF LIFE. PAPERS ALSO ALLEGE EXCESSIVE CHROMIUM AND COBALT BLOOD LEVELS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, LOSS OF ENERGY, IMMOBILIZATION, AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES INCREASED RISK OF PREMATURE FAILURE OF THE REPLACEMENT DEVICE AND SUBSEQUENT DEVICES AND OTHER COMPLICATIONS FROM PREMATURE REVISION SURGERY AND DIMINUTION IN QUALITY OF LIFE. PAPERS ALSO ALLEGE EXCESSIVE CHROMIUM AND COBALT BLOOD LEVELS. UPDATE: (B)(6) 2013 - 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 60 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2576772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other