BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2202322 · Received August 8, 2011

    Report

    Report Number
    1818910-2011-15250
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 14, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT ON OR ABOUT (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY ASR HIP. SOON AFTER, PT BEGAN HAVING PAIN AND/OR STIFFNESS IN HER HIP AREA. PT IS EXPECTED TO UNDERGO ANOTHER SURGERY IN THE NEAR FUTURE TO REMOVE AND REPLACE THE ASR HIP. UPDATE (B)(6) 2011 - MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT SYNOVIAL TISSUE HAD METAL DEBRIS IN IT. ADDITIONALLY, THERE WAS TINGLING AND STAINING OF THE SYNOVIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 87KWA KWA DEPUY INTL., LTD. NA 2859592

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention