BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 9502124 · Received December 20, 2019

    Report

    Report Number
    3005180920-2019-01094
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 2, 2019
    Report Date
    April 24, 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

    Additional Manufacturer Narrative · 0

    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 4 YEARS AFTER PRIMARY. THE SURGEON DOES NOT HAVE PLANS TO REVISE THE PATIENT AT THIS MOMENT. REVISION SURGERY HAS NOT BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2019: LOT 153500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2015. EXPIRATION DATE: 2020-06-30. 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 4 YEARS AFTER PRIMARY. THE SURGEON DOES NOT HAVE PLANS TO REVISE THE PATIENT AT THIS MOMENT. MORE DETAILS TO FOLLOW ONCE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302670 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205R 153500 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Other