BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2851182 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-22372
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    August 9, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, AND LOSS OF ENERGY. ALLEGED ALSO IS IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES. LITIGATION ALSO STATED EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN PATIENT'S BLOOD. THE DOI WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HEAD FEMORAL HEAD KXA DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention