BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3984277 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03028
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    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

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING AN INSERT EXCHANGE AFTER A FALL INVOLVING A TRIATHLON PS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT FELL AND OPENED HIS KNEE AFTER APPROXIMATELY A WEEK AFTER SURGERY. THE SURGEON PERFORMED A WASH OUT AND REVISED THE INSERT. THE REASON FOR REVISING THE INSERT WAS NOT SPECIFIED. THE INVESTIGATION CONCLUDED THE EVENT WAS CAUSED BY THE REPORTED FALL. THERE IS NO EVIDENCE THIS EVENT IS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE. PATIENT FELL AND OPEN HIS KNEE, DOCTOR WENT IN, WASH AND PUT NEW PLASTIC.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE. PATIENT FELL AND OPEN HIS KNEE, DOCTOR WENT IN, WASH AND PUT NEW PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461632 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MNA6PK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention