BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3192584 · Received June 27, 2013

    Report

    Report Number
    0002249697-2013-02088
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 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

    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

    THE DEVICE HISTORY REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. NEED REVISION REPORTS AND CLINICAL HISTORY DESCRIBING THE REPORTED EVENT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO PRODUCT WAS RETURNED FOR REVIEW AND INSUFFICIENT PATIENT MEDICAL RECORDS WERE PROVIDED FOR INSPECTION. ADDITIONAL INFORMATION SUCH AS REVISION OPERATIVE REPORTS CLINICAL HISTORY DESCRIBING THE REPORTED EVENT, AND EXAMINATION OF THE EXPLANTED COMPONENTS WOULD BE REQUIRED FOR FURTHER REVIEW. BASED ON THE INFORMATION PROVIDED AT THE TIME OF INVESTIGATION, NO NON-CONFORMANCES HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A KNEE REVISION. PATIENT HAD SOME FLEXION, AND INSTABILITY. SURGEON CHANGED TO UNIVERSAL BASEPLATE AND PUT IN A TS INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A KNEE REVISION. PATIENT HAD SOME FLEXION, AND INSTABILITY. SURGEON CHANGED TO UNIVERSAL BASEPLATE AND PUT IN A TS INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293953 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MJJ97J

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention