BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI TS BASEPLATE SIZE 3

    MDR report key: 3852135 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02126
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING BASEPLATE LOOSENING INVOLVING A TRI TS BASEPLATE SIZE 3 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS WERE NOT PERFORMED AS NO ITEMS WERE RETURNED. DEVICE HISTORY REVIEW REVEALED THAT ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW REVEALED THAT THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS, X-RAYS OR DEVICE WERE PROVIDED FOR EVALUATION WHICH IS NEEDED TO DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT KNEE REVISED DUE TO LOOSE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329727 TRI TS BASEPLATE SIZE 3 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH IXRBA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention