BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 2926094 · Received January 23, 2013

    Report

    Report Number
    0002249697-2013-00183
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. THE EVENT WAS NOT CONFIRMED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE DEVICES WERE NOT MADE AVAILABLE FOR EVALUATION AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    SURGEON REVISED BECAUSE SCARRING DOWN AND DIDN'T LIKE RANGE. SURGEON OPENED KNEE AND TOOK TIBIAL OUT AND CHANGED ROTATION. PUT IN A NEW TIBIA.

    Description of Event or Problem · 1

    SURGEON REVISED BECAUSE SCARRING DOWN AND DIDN'T LIKE RANGE. SURGEON OPENED KNEE AND TOOK TIBIAL OUT AND CHANGED ROTATION. PUT IN A NEW TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32528 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKML2K

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention