BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R

    MDR report key: 17413516 · Received July 28, 2023

    Report

    Report Number
    3005180920-2023-00611
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2103037: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-04-20. 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 1 YEAR 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER (11 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337216 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2103037 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention