BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3150578 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-04455
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    February 17, 2011
    Report Date
    January 12, 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
    NM, US
    Reporter Occupation
    ATTORNEY

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT BEGAN EXPERIENCING SYMPTOMS RELATED TO THE DEFECTIVE ASR HIP, INCLUDING BUT NOT LIMITED TO, DISCOMFORT, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, AND SLEEP AMONG OTHER THINGS. IT IS FURTHER ALLEGED THAT THE PATIENT WILL NEED REVISION SURGERY IN THE FUTURE. DOI: (B)(6) 2006 - NO REVISION SURGERY REPORTED AT THIS TIME UPDATE (B)(4) 2012 PATIENT FACT SHEET (PFS) FORM AND IMPLANT STICKERS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION, REVISION DATE AND THE REVISION SURGEONS NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250548 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2178029

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention