BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSERVE A-CLASS

    MDR report key: 2111899 · Received May 29, 2011

    Report

    Report Number
    2111899
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 29, 2011
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DID WELL INITIALLY BUT WAS SEEN EARLIER THIS YEAR WITH COMPLAINTS OF CLUNKING IN HIS HIP. BECAUSE HE HAD A METAL ON METAL HIP, METAL LEVELS FOR COBALT, NICKEL, AND CHROMIUM WERE OBTAINED. THE CHROMIUM AND COBALT LEVELS WERE BOTH ELEVATED. HIS FIRST ARTHROPLASTY WAS A CEMENTLESS FEMORAL COMPONENT AND ACETABULAR COMPONENT WITH A CERAMIC-ON-CERAMIC LINER. HE HAD SOME DIFFICULTY WITH DISLOCATION IN THE POSTOPERATIVE PERIOD AND ULTIMATELY PROCEEDED WITH A REVISION ARTHROPLASTY IN 2007. HIS ARTHROPLASTY WAS LOOSE, AND HE HAD SIGNIFICANT HETEROTOPIC OSSIFICATION. THE HIP ARTHROPLASTY AT THAT POINT WAS CHANGED TO A PROFEMUR-Z STEM WITH A LONG MODULAR TITANIUM NECK AND A METAL-ON-METAL ARTICULATION. HE GOT ON REASONABLY WELL UNTIL RECENTLY WHEN HE PRESENTED IN THE CLINIC WITH A FEELING OF RATCHETING IN HIS HIP. EVALUATION OF METAL LEVELS REVEALED THEM TO BE ELEVATED AND WE RECOMMENDED THAT HE HAVE REVISION OF THE ARTHROPLASTY LEST HE DEVELOP A MORE SIGNIFICANT METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE A-CLASS PROSTHESIS, HIP, FEMORAL HEAD KWY WRIGHT MEDICAL 38AM5400 *
    2 MODULAR NECK; 12/14 5 43'30 MODULAR NECK KWY WRIGHT MEDICAL LN PAO1254 *
    3 * ACETABULAR CUP KWB WRIGHT MEDICAL 38SP60ID *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR