BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS PROXIMAL TIBIAL STANDARD

    MDR report key: 3781132 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01694
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING CUSTOM FEMORAL COMPONENT AND TIBIAL STEM LOOSENING INVOLVING AN GMRS PROXIMAL TIBIA STANDARD WAS REPORTED. CONCLUSION: THERE IS NO INDICATION OR ALLEGATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION MAY HAVE CONTRIBUTED TO THIS EVENT OF TIBIAL STEM AND CUSTOM FEMORAL COMPONENT LOOSENING.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN PROXIMAL TIBIAL COMPONENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL EVENT DESCRIPTION RECEIVED IN THE EMAIL FROM REPORTER RECEIVED 05/10/14: PATIENT WAS PLAYING TENNIS AND WITH HER FOOT PLANTED, MADE A TWIST AND FELT THE SENSATION IN THE KNEE. AT SURGERY THE KRH FEMUR WAS FOUND TO BE LOOSE. THE GMRS PROX TIBIA WAS LOOSE. THE COMPONENTS WERE REPLACED WITH A SMALL GMRS DISTAL FEMUR AND A SMALL GMRS PROXIMAL FEMUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT APPEARS THAT THE PROXIMAL TIBIAL COMPONENT MAY BE LOOSE. REVISION IS SCHEDULED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260706 GMRS PROXIMAL TIBIAL STANDARD IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH PD030618

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other