BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5

    MDR report key: 4447572 · Received January 23, 2015

    Report

    Report Number
    0002249697-2015-00179
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    December 31, 2014
    Report Date
    December 31, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ELEVATED COBALT AND CHROME (ALTR) INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS INDICATED THAT: "CAN NOT CONFIRM EVENT DESCRIPTION, NEED HISTOLOGICAL DIAGNOSIS, X-RAYS AND MRI IMAGES." COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PATHOLOGY REPORTS, PROGRESS NOTES, X-RAYS, MRI IMAGES AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT LABS ELEVATED COBALT CHROME LEVELS. SOFT TISSUE DAMAGE PRESENT, NECROSED TISSUE INSIDE CAPSULE.

    Description of Event or Problem · 1

    PATIENT LABS ELEVATED COBALT CHROME LEVELS. SOFT TISSUE DAMAGE PRESENT, NECROSED TISSUE INSIDE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55918 ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 37502101

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention