BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 3223643 · Received July 12, 2013

    Report

    Report Number
    0002249697-2013-02272
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS 188 CENTIMETERS IN HEIGHT. THE REPORTER STATED, "I BELIEVE THE TIBIA WAS SUSPECTED OF BEING LOOSE. FRAGMENT WERE FOUND WITHIN AND NOT A RESULT OF REMOVAL." AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE REVISION OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    KNEE REVISED FOR TIBIA LOOSENING AND WHEN REMOVING COMPONENTS, IT WAS DISCOVERED THAT THE POLY INSERT HAD SOME BROKEN FRAGMENTS.

    Description of Event or Problem · 1

    KNEE REVISED FOR TIBIA LOOSENING AND WHEN REMOVING COMPONENTS, IT WAS DISCOVERED THAT THE POLY INSERT HAD SOME BROKEN FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324601 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention