BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIYE 4/12 MM L

    MDR report key: 12038960 · Received June 22, 2021

    Report

    Report Number
    3005180920-2021-00522
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826573
    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 09 JUNE 2021: LOT 1910170: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-JAN-2020. EXPIRATION DATE: 2024-12-09. 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

    23 DAYS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO SUSTAINING A QUADRICEPS STRAIN. THE CAUSE OF THE DEVELOPMENT OF THE QUADRICEPS STRAIN IS UNKNOWN. THE SURGEON SUTURED THE PATIENT'S QUADRICEPS AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935466 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIYE 4/12 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0412FL 1910170 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention