BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

    MDR report key: 8478383 · Received April 3, 2019

    Report

    Report Number
    3005180920-2019-00220
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 4, 2019
    Report Date
    April 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 APRIL 2019: LOT 183041: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-17. 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: BATCH REVIEW PERFORMED ON 03 APRIL 2019: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R LOT. (K090988), LOT 186206: 110 ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2018. EXPIRATION DATE: 2023-11-12. 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.

    Description of Event or Problem · 1

    DURING THE PRIMARY KNEE SURGERY AND WHILE ATTEMPTING TO ENGAGE THE 10MM INSERT SCREW WITH THE TIBIAL TRAY, IT WAS DISCOVERED THAT SCREW WOULD NOT ENGAGE. AN 11MM INSERT WAS OPENED AND THE SCREW FROM THAT INSERT WAS USED IN THE 10MM INSERT WITH NO ISSUES. THIS CAUSED A 2-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270683 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R TIBIAL KNEE FLEX INSERT JWH MEDACTA INTERNATIONAL SA 183041 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other