BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3190344 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-06387
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 7, 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
    CA, 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: ON (B)(6) 2006, PATIENT WAS IMPLANTED WITH DEPUY ASR HIP IMPLANT ON HER LEFT SIDE. PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIP. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, AND TO RISE FROM A SEATED POSITION. EIGHT MONTHS AFTER PATIENT RECEIVED HER ASR HIP IMPLANT, HER SURGEON CONCLUDED THAT THE HIP IMPLANT HAD FAILED AND NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289788 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2084433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other