BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 3171351 · Received June 14, 2013

    Report

    Report Number
    0002249697-2013-01924
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. DHR REVIEW FOR THIS LOT WAS SATISFACTORY. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE INVESTIGATION CONCLUDED THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED FURTHER INFORMATION IS NEEDED TO DETERMINE THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME,

    Description of Event or Problem · 1

    BOOKED KNEE REVISION, FOLLOWING A FRACTURE OF THE LATERAL TIBIAL PLATEAU, RESULTING IN KNEE INSTABILITY. TIBIAL REVISION ONLY UNDERTAKEN AS FEMUR WAS WELL FIXED.

    Description of Event or Problem · 1

    BOOKED KNEE REVISION, FOLLOWING A FRACTURE OF THE LATERAL TIBIAL PLATEAU, RESULTING IN KNEE INSTABILITY. TIBIAL REVISION ONLY UNDERTAKEN AS FEMUR WAS WELL FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271929 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SYSHP

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O| R