BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2

    MDR report key: 7338217 · Received March 14, 2018

    Report

    Report Number
    3005180920-2018-00136
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    February 12, 2018
    Report Date
    May 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819346
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 MARCH 2018; LOT 172153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2017. EXPIRATION DATE: 2022-05-28 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/23MM REFERENCE 02.07.0223SCF (K103170): LOT 145726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 OCTOBER 2014. EXPIRATION DATE: 2019-09-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT GMK-REVISION FEMUR REVISION PS SIZE2 L REFERENCE 02.07.2402L (K102437) LOT 172147: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2017. EXPIRATION DATE: 2022-05-23 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT

    Additional Manufacturer Narrative · 1

    THE SURGEON REVISED THE PATIENT ON APRIL 10TH USING COMPETITOR IMPLANTS AND CEMENTED STEMS. HE REMOVED MEDACTA PS FEMUR AND TIBIA WITH STEMS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 MEDACTA HAS BEEN INFORMED BY THE SALES AGENT THAT PATIENT CAME IN COMPLAINING OF INSTABILITY. SURGEON PLANS TO REMOVE IMPLANTS AND INPUT ANOTHER COMPANY'S PRODUCT. ON (B)(6) 2018 WE WERE INFORMED THAT PATIENT REVISION SURGERY HAS NOT BEEN RESCHEDULED YET, MAYBE IT WILL BE DONE IN (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180100 GMK REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 172153 07630030819346

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention