BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB LG 9

    MDR report key: 2971389 · Received February 21, 2013

    Report

    Report Number
    0002249697-2013-00732
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING WEAR INVOLVING A DURA DURATION A/P TIB LG 9 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A REVIEW OF THE PROVIDED MEDICAL INFORMATION COULD NOT CONFIRM THE EVENT OR DETERMINE A ROOT CAUSE. 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. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES,FURTHER DATED X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT'S KNEE WAS REVISED. THE INSERT WAS REPLACED WITH 6642-1-809.

    Description of Event or Problem · 1

    THE PATIENT'S KNEE WAS REVISED. THE INSERT WAS REPLACED WITH 6642-1-809.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76861 DURA DURATION A/P TIB LG 9 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH VSMHA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R