BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R

    MDR report key: 14072426 · Received April 11, 2022

    Report

    Report Number
    3005180920-2022-00252
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862632
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-APR-2022: LOT 2000446: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2024-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 07-APR-2022: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED # T3-I4 R (K121416) LOT 2013025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO THE POLY DISENGAGING FROM THE TIBIAL TRAY AS THE PATIENT WAS GOING UP AND DOWNSTAIRS. PRIMARY PERFORMED IN (B)(6) 2021. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490002 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0413FR 2000446 07630030862632

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention