BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY - ULTAMET - METAL ON METAL INSERT

    MDR report key: 2928471 · Received January 17, 2013

    Report

    Report Number
    MW5028673
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 5, 2015
    Report Date
    February 15, 2015
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON 02/18/2015 FROM THE REPORTER: THIS IS THE SECOND REPORT FROM THE SAME ISSUE WITH ADD'L AND MORE SEVERE INFO. LINKS TO ACCESS NUMBER - MW5028673. THIS PT HAD A NOM HIP IMPLANT (DEPUY) IN (B)(6) 2005 AND HAS EXPERIENCED ISSUES WITH ELEVATED CHROMIUM AND COBALT LEVELS. THESE HAVE BEEN MONITORED SINCE 2012 WITH CONTINUED ELEVATION. WITH THE LAST TESTS, THE SURGEON HAS RECOMMENDED REVISION SURGERY. LAST TEST RESULTS WERE COBALT - 45.8 AND CHROMIUM 17.3 - ADDITIONALLY, THIS PT OVER THE LAST 6 MONTHS HAS BEEN EXPERIENCING OTHER HEALTH ISSUES, THAT MAY BE A CONTRIBUTING FACTOR TO THE HIGH ELEVATION OF CHROMIUM AND COBALT. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2015. ALL DEVICES - ULTAMET ((B)(4)) - METAL ON METAL INSERT - LOT 1914174 BARCODE INFO - C0851218873541M / 31006261914174ME 2. DEPUY ACETABULAR CUP - ((B)(4)) - LOT Z2HEN1000 3. DEPUY SUMMIT TAPERED HIP STEM W/ POROCOAT - ((B)(4)) - LOT Z1BY1000 4. ARTICUL/EZE M METAL ON METAL FEMORAL HEAD - ((B)(4)) - LOT - 1947493 BARCODE INFO - E08513655200015 / 310081594749357 ARE: THIS PT HAS A PINNACLE MTL.

    Description of Event or Problem · 1

    PT REC¿D A LEFT HIP REPLACEMENT ON (B)(6) 2005. THE DEVICE IMPLANTED WAS A DEPUY METAL ON METAL FULL HIP REPLACEMENT. CURRENTLY PT HAS ELEVATED CHROMIUM AND COBALT BLOOD TEST RESULTS CHROMIUM CONFIRMED WITH SECOND TEST. ARTHRITIS WAS CAUSE THAT HIP REPLACEMENT WAS NEEDED. PT IS ALSO EXPERIENCING SOME SYSTEMS SUCH AS METAL TASTE IN HIS MOUTH WHEN DRINKING WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25543 DEPUY - ULTAMET - METAL ON METAL INSERT METAL ON METALL HIP INSERT KWA 121887354 1914174
    25544 DEPUY SUMMIT TAPERED HIP STEM W/POROCOAT NONE LWJ Z1BY1000
    25545 DEPUY- ACETABULAR CUP NONE KWA Z2HEN1000
    25546 ARTICUL/EZE M METAL/METAL FEMORAL HEAD NONE JDI 1947493

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R| S