BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB SM 13

    MDR report key: 3103423 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01607
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    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

    THE EVENT WAS NOT CONFIRMED AS NO DEVICES WERE RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL RECORDS WERE RECEIVED. 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 EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN I&D DUE TO PAIN. POLY SWAP WAS ALSO PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN I&D DUE TO PAIN. POLY SWAP WAS ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203760 DURA DURATION A/P TIB SM 13 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH 36587001

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention