BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 19457185 · Received June 4, 2024

    Report

    Report Number
    3005180920-2024-00371
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 4, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-MAY-2024: LOT 2202597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2022. EXPIRATION DATE: 2027-05-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 10-MAY-2024: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L (K121416) LOT 2207342: 36 ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0210CRL TIBIAL INSERT FIXED SPHERE CR SIZE 2/10 MM L (K181635) LOT 2104780: 30 ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2021. EXPIRATION DATE: 2026-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608736 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2202597 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention