BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 9563574 · Received January 8, 2020

    Report

    Report Number
    3005180920-2019-01114
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    December 9, 2019
    Report Date
    March 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REASON FOR FOLLOW UP: REVISION SURGERY PERFORMED THE PATIENT CAME IN FOR A POST-OP CHECK-UP AND IT WAS DETERMINED THAT THE PATIENT HAD AN ASEPTIC LOOSENING OF THE TIBIAL TRAY 3 YEARS AFTER PRIMARY. THE CAUSE OF THE ASEPTIC LOOSENING IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY AND ADDED A CONE AND EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 DECEMBER 2019: LOT 162466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2016. EXPIRATION DATE: 2021-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP CHECK-UP AND IT WAS DETERMINED THAT THE PATIENT HAD AN ASEPTIC LOOSENING OF THE TIBIAL TRAY 3 YEARS AFTER PRIMARY. THE SURGEON DOES NOT PLAN TO REVISE THE PATIENT AT THIS TIME ((B)(6) 2020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29247 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1205R 162466 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Other