BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2923499 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-00486
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    August 23, 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
    TX, 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 SUFFERS THE FOLLOWING: CONSTANT PAIN IN HIS LEFT HIP WITH PAIN RADIATING UP TO HIS CHEST AREA UNDER HIS ARM AND RIB CAGE, THE FEELING OF A PINCH AROUND THE HIP IMPLANT THAT REQUIRES HIM TO READJUST HIS POSITION TO MAKE IT STOP, DIFFICULTY PERFORMING HIS EVERYDAY ACTIVITIES AND FUNCTIONING FROM DAY TO DAY, NAUSEA OF UNKNOWN ETIOLOGY, DIFFICULTY STAYING FOCUSED, AND THE BEGINNING OF ISSUES WITH HIS SKIN. THE PATIENTS METAL ION LEVELS ARE BEING MONITORED BY HIS SURGEON AND IS CONCERNED ABOUT THE POSSIBILITY OF REVISION SURGERY AND THE FUTURE HEALTH EFFECTS OF ELEVATED METAL IONS IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30187 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2721773

    Patients

    Seq Age Sex Outcome Treatment
    1 Other