BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3021144 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-02818
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    August 4, 2010
    Report Date
    April 18, 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
    CA, 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

    ADDITIONAL INFO CATALOG AND LOT #. UPDATE - (B)(4) 2013 - PPD RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED FOR THE FEMORAL HEAD. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING ASR CUP LOOSENING. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO SEVERE METAL POISONING, METALLOSIS AND METAL DEBRIS WITHIN THE JOINT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124505 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2523811

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention