BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #6

    MDR report key: 3081023 · Received April 26, 2013

    Report

    Report Number
    0002249697-2013-01452
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE HOSPITAL'S POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN ALLERGY/REACTION INVOLVING AN ACCOLADE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED BASED ON THE CASE DESCRIPTION AND INDICATED THAT THE ROOT CAUSE OF FAILURE COULD NOT BE ESTABLISHED BASED ON THE CURRENT SET OF INFORMATION. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. 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, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION BECAUSE OF PSEUDO TUMOR AND PAIN. ONCE IN FOUND METALLOSIS OF THE TRUNION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION BECAUSE OF PSEUDO TUMOR AND PAIN. ONCE IN FOUND METALLOSIS OF THE TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182846 ACCOLADE PLUS TMZF HIP STEM #6 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 38349501

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| O| R