BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R

    MDR report key: 13963189 · Received March 31, 2022

    Report

    Report Number
    3005180920-2022-00208
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825521
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MARCH 2022: LOT 120877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2012. EXPIRATION DATE: 2017-05-31. 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 SINCE 2018. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 MARCH 2022: GMK-HINGE 02.09.0112H FIXED TIBIAL INSERT SIZE 1/12MM (K130299) LOT. 143001. LOT 143001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2014. EXPIRATION DATE: 2019-06-30. 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 SINCE 2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR PATELLA, MEDACTA TIBIAL TRAY, AND MEDACTA POLY 4 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105052 GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R FIXED TIBIAL TRAY KRO MEDACTA INTERNATIONAL SA 02.09.4001R 120877 07630030825521

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention