BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 LAT COXA VARA SIZE 11

    MDR report key: 3021413 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-04366
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    July 10, 2012
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    LZO
    PMA / PMN Number
    K042992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND HIGH COBALT LEVELS. UPDATE (B)(4) 2013 - LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, SIGNIFICANT SYNOVITIS AND OTHER INJURIES RELATING TO ELEVATED METAL IONS IN HER BLOOD. (B)(4) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS METAL WEAR DEBRIS. UPON REVISION A YELLOW/BROWN/GREY FLUID WAS FOUND, THERE WAS BURNISHING ON THE WEIGHTBEARING PORTION OF THE ARTICULATING DEVICES, AND THERE WAS CORROSION FOUND AROUND THE MORSE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123208 CORAIL2 LAT COXA VARA SIZE 11 STEM LZO DEPUY FRANCE 2332612

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR