BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #2

    MDR report key: 3123144 · Received May 21, 2013

    Report

    Report Number
    0002249697-2013-01737
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    January 4, 2005
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND ALLERGY/REACTION INVOLVING AN ACCOLADE STM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED ISSUE WITH PAIN AND DIFFICULTY WALKING 9-YEARS POST PRIMARY IMPLANTATION OF AN ACCOLADE TMZF STEM WITH TRIDENT CUP. SURGICAL REPORT OF PRIMARY ARTHROPLASTY SHOWS NO ISSUES WHILE THE LAB REPORTS SOMEWHAT ELEVATED COBALT AND CHROME LEVELS IN THE PATIENT¿S URINE ALTHOUGH BLOOD CHROME IS NORMAL BUT BLOOD COBALT SLIGHTLY ELEVATED. IN THIS CASE, THERE IS NO REASON FOR CONCERN AS BASED UPON THE OBSERVED METAL ION VALUES. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE PAIN COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN RIGHT HIP. PATIENT CAN'T HARDLY WALK. PATIENT STATES THAT SHE HAS GONE TO HER SURGEON MANY TIMES FOR X-RAYS. ACCORDING TO THE X-RAYS THE SURGEON SAYS EVERYTHING IS FINE. IN (B)(6) OF 2012 PATIENT STARTED HAVING ELEVATED COBALT AND CHROMIUM LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN RIGHT HIP. PATIENT CAN'T HARDLY WALK. PATIENT STATES THAT SHE HAS GONE TO HER SURGEON MANY TIMES FOR X-RAYS. ACCORDING TO THE X-RAYS THE SURGEON SAYS EVERYTHING IS FINE. IN (B)(6) OF 2012 PATIENT STARTED HAVING ELEVATED COBALT AND CHROMIUM LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223677 ACCOLADE PLUS TMZF HIP STEM #2 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 10042702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other