BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 3781236 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01634
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING BONE LOSS INVOLVING A TRIATHLON PRIM TIB BASEPLATE - CEMENTED WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, PATIENT MEDICAL RECORDS, AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID TOTAL REVISION OF A RIGHT KNEE. THERE WAS A TRIATHLON KNEE IN, THAT WAS REMOVED AND REPLACED WITH A TRIATHLON TS PROSTHESIS. BOTH THE FEMUR AND TIBIA WERE REVISED, DUE TO BONE LOSS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID TOTAL REVISION OF A RIGHT KNEE. THERE WAS A TRIATHLON KNEE IN, THAT WAS REMOVED AND REPLACED WITH ATRIATHLON TS PROSTHESIS. BOTH THE FEMUR AND TIBIA WERE REVISED, DUE TO BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259097 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH OWRE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention