BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #5

    MDR report key: 3926417 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02616
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN SIZE 5 TIBIAL BASEPLATE. OTHER DEVICES LISTED IN THIS REPORT: CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: TRIATHLON TOTAL KNEE SIZE 4 FEMORAL COMPONENT; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: 36MM PATELLA X3; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: 9MM X3 CS TIBIAL BEARING. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A TRIATHLON PRIM CEM FXD BPLT #5 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISION WAS DUE TO PAINFUL KNEE. SURGEON TOOK OUT POLY BEARING AND ALSO THE BASEPLATE. THERE WAS NO MENTION OF ANY MECHANICAL FAILURE BY THE SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISION WAS DUE TO PAINFUL KNEE. SURGEON TOOK OUT POLY BEARING AND ALSO THE BASEPLATE. THERE WAS NO MENTION OF ANY MECHANICAL FAILURE BY THE SURGEON

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403992 TRIATHLON PRIM CEM FXD BPLT #5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH EEMHB

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention