BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3160284 · Received June 10, 2013

    Report

    Report Number
    1818910-2013-18529
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 31, 2013
    Report Date
    August 17, 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
    WI, 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. 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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE OF RIGHT HIP DUE TO PAIN.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013-LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM EXCESSIVE LEVELS OF CHROMIUM AND COBALT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259355 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2952930

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention