BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 14267053 · Received May 3, 2022

    Report

    Report Number
    3005180920-2022-00333
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-APRIL-2022: LOT 1900411: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2019. EXPIRATION DATE: 2024-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 10 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT (NEW ONE IS 17MM HIGH) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183587 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 1900411 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention