BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 20237262 · Received September 17, 2024

    Report

    Report Number
    3005180920-2024-00742
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    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 27 AUGUST 2024 LOT 2339978: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-FEB-2024. EXPIRATION DATE: 2029-01-17. 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 COMPONENT INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 27 AUGUST 2024 GMK-SPHERIKA 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS (K202022) LOT 2338088: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-OCT-2023. EXPIRATION DATE: 2028-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 27 AUGUST 2024 GMK-SPHERIKA 02.12.KA06R FEMORAL COMPONENT SPHERIKA CEMENTED S6R (K211004) : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2023. EXPIRATION DATE: 2028-11-07. 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

    REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 MONTHS FROM THE PRIMARY SURGERY THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809602 GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2339978 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention