BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L

    MDR report key: 16635903 · Received March 29, 2023

    Report

    Report Number
    3005180920-2023-00206
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862649
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 MARCH 2023 LOT 1904544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JULY-2019. EXPIRATION DATE: 2024-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS DUE TO THE FORMATION OF EXCESS SCAR TISSUE. THE SURGEON REMOVED SCAR TISSUE AND SWAPPED THE POLY (11 TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766623 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L KNEE TIBIAL FIXED INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0511FL 1904544 07630030862649

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention