BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3082033 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-06751
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    August 9, 2013
    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
    MO, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATON CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO ELEVATED ION LEVELS.

    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. 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
    185709 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2173607

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention