BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM R

    MDR report key: 12047794 · Received June 23, 2021

    Report

    Report Number
    3005180920-2021-00504
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    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 31 MAY 2021: LOT 1904560: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JULY-2019. EXPIRATION DATE: 2024-06-29. 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

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. 1 YEAR AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S4L - 12 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4R - 17MM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949036 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM R TBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0412FR 1904560 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention