BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3062218 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-01690
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    June 29, 2011
    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
    NC, 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. REF. (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 FOLLOWING: AFTER HIS SURGERY, PATIENT BEGAN SUFFERING PAIN IN HIS HIP. PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY AND CONSISTENT AND CONTINUAL PAIN AND SUFFERING. ***UPDATE*** 6/29/2011 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(4) 2011. CHANGED UNK ASR HIP TO ASR CUP ADDED FEMORAL HEAD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163644 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2356006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other