BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 8019248 · Received October 30, 2018

    Report

    Report Number
    3005180920-2018-00840
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2018. LOT :153512: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT ((B)(4)). ADDITIONAL COMPONENT REVISED: GMK-PRIMARY 02.07.0520FUC TIBIAL INSERT UC FIXED # 5/20 MM, LOT: 133340: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 OCTOBER 2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN SOLD. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON OCT 26, 2018: SECOND REVISION SURGERY DUE TO JOINT INSTABILITY IN A (B)(6) YEAR-OLD MAN. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. ACCORDING TO THE SURGEON TIBIAL BASEPLATE WAS ALSO LOOSE. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY CASE ON FEB 22, 2016. ON (B)(6) 2017, THE PATIENT CAME IN COMPLAINING OF LAXITY. THE SURGEON REVISED THE INSERT. COMPLAINT (B)(4) WAS FILED. ON (B)(6) 2018, THE PATIENT WAS REVISED AGAIN (2 YEARS AND A HALF FROM PRIMARY SURGERY) DUE TO INSTABILITY. THE PATIENT BECAME UNSTABLE OVER TIME. THE SURGEON REVISED THE INSERT AND THE TIBIAL TRAY. THE TIBIAL TRAY WAS REVISED BECAUSE THE SURGEON BELIEVED THAT THE TRAY WAS A LITTLE LOOSE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860891 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 153512 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention