BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2953842 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-03862
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 23, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K046027
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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. (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 PSEUDOTUMOR. UPDATE CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, OSTEOLYSIS, AND ADVERSE LOCAL TISSUE REACTION. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT, SEVERE PAIN, SIGNIFICANT INABILITY TO WALK AND/OR MOVE, AND BONE EROSION. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58182 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HIP KWA DEPUY INTERNATIONAL 2157482

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention