BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #7

    MDR report key: 3984394 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03046
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING TIBIAL TRAY LOOSENING INVOLVING A TRIATHLON PRIM CEM FXD BPLT #7 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICE AND/OR MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION OF LEFT KNEE DUE TO LOOSENING. DOCTOR REMOVED TIBIAL TRAY AND INSERT. THE TRAY THAT WAS IMPLANTED WAS IDENTIFIED AS BEING LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION OF LEFT KNEE DUE TO LOOSENING. DOCTOR REMOVED TIBIAL TRAY AND INSERT. THE TRAY THAT WAS IMPLANTED WAS IDENTIFIED AS BEING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460719 TRIATHLON PRIM CEM FXD BPLT #7 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SBCJD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention