BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 2925848 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-02240
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ALLEGES PATIENT HAD PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS AFTER ASR HIP IMPLANTS. ((B)(4) 2012) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. (B)(4) 2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED FOR THEIR RIGHT HIP. RECORDS INDICATE NECROTIC TISSUE FROM CORROSION WEAR WAS FOUND UPON REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29603 ADAPTER SLEEVES 12/14 +5 SLEEVE KWA DEPUY INTERNATIONAL 210085

    Patients

    Seq Age Sex Outcome Treatment
    1