BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM

    MDR report key: 3120463 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01710
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION AND NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REMOVED AND UPSIZED INSERT THICKNESS TO A #5 22MM TS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REMOVED AND UPSIZED INSERT THICKNESS TO A #5 22MM TS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222685 NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKP1J3

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention