BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    MDR report key: 3252810 · Received July 29, 2013

    Report

    Report Number
    0002249697-2013-02478
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    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 DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, X-RAY IMAGES, OPERATIVE REPORTS, AND PATIENT FOLLOW-UP NOTES ARE NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TS INSERT WAS REVISED BECAUSE OF HYPER EXTENDED KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TS INSERT WAS REVISED BECAUSE OF HYPER EXTENDED KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352899 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLE88W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention