BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 3870820 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20915
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    September 23, 2013
    Report Date
    May 19, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO THE RECALL. LEGAL CLAIM RECEIVED (B)(6) 2014. UPDATE REC¿D (B)(6) 2014 - LITIGATION RECEIVED WHICH MAKES EVENT REPORTABLE. LITIGATION ALLEGES PAIN DUE TO ASR FAILURE AND DISLOCATIONS AFTER THE REVISION SURGERY, WHICH PROMPTED FURTHER REVISIONS AND RESULTED IN INFECTION. THE CUP AND HEAD ARE NOW BEING REPORTED. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347647 ASR ACETABULAR CUPS 48 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2064568

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention