BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 18703839 · Received February 14, 2024

    Report

    Report Number
    3005180920-2024-00052
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 24, 2024
    Report Date
    February 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    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 30-JAN-2024 LOT 2305872: 24 ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2023. EXPIRATION DATE: 2028-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 30-JAN-2024: GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L (K121416) LOT 2307456: 108 ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2023. EXPIRATION DATE: 2028-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 93 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS (K202022) LOT 2307912: 75 ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2023. EXPIRATION DATE: 2028-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 63 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER 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
    1389823 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2305872 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention