BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2852727 · Received November 30, 2012

    Report

    Report Number
    1818910-2012-28021
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    April 19, 2011
    Report Date
    November 14, 2012
    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
    VT, 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2012: LITIGATION DOCUMENTS WERE RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERED DEBILITATING PAIN AND DISCOMFORT IN HIPS AND LEGS, THEREBY INTERFERING WITH PLAINTIFFS ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING. **UPDATE** (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH INDICATES THAT PATIENT IS SEEKING LEGAL ACTION. PART/LOT INFORMATION FOR THE FEMORAL HEAD AND SIDE WERE ALSO IDENTIFIED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2571074

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other