BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI TS BASEPLATE SIZE 4

    MDR report key: 3852208 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02145
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A TRI TS BASEPLATE SIZE 4 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. BASED ON THE LIMITED INFORMATION AND REPORTED EVENT, THE INVESTIGATION CAN CONCLUDE THAT THE PERIPROSTHETIC FRACTURE WAS DUE TO THE PATIENT¿S FALL. HOWEVER, NO MEDICAL RECORDS, X-RAYS OR DEVICE WERE PROVIDED FOR EVALUATION WHICH IS NEEDED TO DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL AFTER TOTAL KNEE PROCEDURE AND SUSTAINED A FRACTURED TIBIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL AFTER TOTAL KNEE PROCEDURE AND SUSTAINED A FRACTURED TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328749 TRI TS BASEPLATE SIZE 4 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH KKAKA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention