BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #1

    MDR report key: 3202573 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02203
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN ALLERGY REACTION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS PERFORMED BASED ON THE CASE DESCRIPTION AND CONCLUDED THAT A ROOT CAUSE OF FAILURE CANNOT BE ESTABLISHED WITH CURRENT SET OF INFORMATION. DEVICE REVIEW INDICATED THAT 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 EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN. THE SURGEON FELT THAT UPON GOING IN FOR REVISION SURGERY HE FOUND A PSEUDO TUMOR ENCAPSULATING THE JOINT AND DECIDED AT THIS TIME TO REMOVE THE LINER, HEAD, AND REPLACE WITH A NEW LINER. C-TAPER ADAPTER AND PLACE A CERAMIC HEAD.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN. THE SURGEON FELT THAT UPON GOING IN FOR REVISION SURGERY HE FOUND A PSEUDO TUMOR ENCAPSULATING THE JOINT AND DECIDED AT THIS TIME TO REMOVE THE LINER, HEAD, AND REPLACE WITH A NEW LINER. C-TAPER ADAPTER AND PLACE A CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301818 ACCOLADE PLUS TMZF HIP STEM #1 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 12933901

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R