BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2864210 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25471
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    April 13, 2011
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE 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. NOT RECEIVED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES THAT BEGAN WITH MILD PAIN AND STIFFNESS BUT INCREASED TO SEVERE DEBILITATING PAIN, SORENESS, WEAKNESS, AND DISCOMFORT; DIFFICULTY WALKING, SLEEPING, AND SITTING FOR SHORT PERIODS OF TIME; DIFFICULTY PERFORMING ROUTINE ACTIVITIES; DIFFICULTY WORKING DUE TO PAIN; INABILITY TO LEAD A NORMAL LIFE; ELEVATED METAL LEVELS, BI-LATERAL REVISION SURGERY AND RESULTING BI-LATERAL DEEP VEIN THROMBOSIS (DVTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention