BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L

    MDR report key: 19381855 · Received May 23, 2024

    Report

    Report Number
    3005180920-2024-00334
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819841
    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 02 MAY 2024 LOT 2200536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2022. EXPIRATION DATE: 2027-04-25. 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. ADDITIONAL REVISED IMPLANTS BATCH REVIEW PERFORMED ON 02 MAY 2024 ON GMK-SPHERE 02.12.0002L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L (K121416) LOT. 2101892 LOT 2101892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-03-23. 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. BATCH REVIEW PERFORMED ON 02 MAY 2024 ON GMK-SPHERE 02.12.0113FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/13 MM L (K140826) LOT. 186001 LOT 186001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2018. EXPIRATION DATE: 2023-09-20. 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 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617479 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2200536 07630030819841

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention