BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #2

    MDR report key: 4241441 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04216
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING TIBIAL BASEPLATE SUBSIDENCE INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE INFORMATION THAT WAS PROVIDED. A ROOT CAUSE CANNOT BE DETERMINED WITHOUT MEDICAL RECORDS, X-RAYS, OPERATIVE NOTES AND FOLLOW-UP NOTES.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN #2 TIBIAL COMPONENT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER 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 THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT KNEE DUE TO SUBSIDED TIBIAL COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT KNEE DUE TO SUBSIDED TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721832 TRIATHLON PRIM CEM FXD BPLT #2 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH ECRHR

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention