BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    MDR report key: 10218039 · Received July 1, 2020

    Report

    Report Number
    3005180920-2020-00372
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 173664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2017. EXPIRATION DATE: 2022-10-05. 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 IMPLANT INVOLVED: GMK-SPHERE 02.12.0417FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R (K121416) LOT. 135217. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 135217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2014. EXPIRATION DATE: 2018-11-31. 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 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 2 YEARS AND 2 MONTHS AFTER THE PRIMARY REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY AND REVISED THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681655 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4R 173664 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention