BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3260577 · Received August 1, 2013

    Report

    Report Number
    1818910-2013-22804
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 10, 2013
    Report Date
    August 1, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    USER FACILITY REPORTED PATIENT HAD LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. THE PATIENT WAS NOTED TO HAVE ELEVATED METAL LEVELS OF CHROMIUM COBALT. THE PATIENT HAD A REVISION OF LEFT HIP WITH REPLACEMENT OF THE ACETABULAR CUP AND SLEEVE ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359536 ASR ACETABULAR CUPS 50 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 1977546

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention