BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 8806994 · Received July 19, 2019

    Report

    Report Number
    3005180920-2019-00600
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    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 10 JULY 2019: LOT 180394: (B)(4) ITEMS MANUFACTURED AND RELEAS:ED ON 25-APRIL-2018. EXPIRATION DATE: 2023-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF TIGHTNESS IN HER KNEE, SO THE SURGEON RELEASED SCAR TISSUE AND REVISED THE 10MM POLY WITH ANOTHER 10MM POLY (PRIMARY SURGERY WAS PERFORMED 3 MONTHS EARLIER). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602446 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 180394 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention