BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 11876967 · Received May 25, 2021

    Report

    Report Number
    3005180920-2021-00424
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    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 ON 07 MAY 2021: LOT 1811462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 2024-03-06. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 07 MAY 2021: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988), LOT 1902689: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-SEP-2019. EXPIRATION DATE: 2024-08-20. 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

    1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT DUE TO THE KNEE BECOMING STUCK IN FLEXION AND THE INABILITY TO EXTEND THE KNEE. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND ADDED AN EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774272 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 1811462 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention