BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11906932 · Received May 31, 2021

    Report

    Report Number
    3005180920-2021-00460
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 31, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MAY 2021: LOT 140345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2014. EXPIRATION DATE: 2019-02-28. 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 2017. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT. 160017. BATCH REVIEW PERFORMED ON 11 MAY 2021: LOT 160017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2016. EXPIRATION DATE: 2021-02-27. 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 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE TIBIAL INSERT SCREW HAD DISENGAGED AND ENDED UP INSIDE OF THE TISSUE. IT WAS ALSO OBSERVED THAT THE TIBIAL INSERT SCREW HAD CAUSED DAMAGE TO THE UNRESURFACED PATELLA. 4 YEARS AND 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE LINER, TIBIAL TRAY AND ADDED AN EXTENSION STEM AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. WHEN THE SURGEON OPERATED ON THE PATIENT, IT WAS OBSERVED THAT THE TIBIAL TRAY WAS ALSO LOOSE, SO THE SURGEON REVISED IT. A TORQUE LIMITING SCREWDRIVER WAS NOT USED DURING THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803141 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0210FR 140345 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention