BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 19178698 · Received April 25, 2024

    Report

    Report Number
    3005180920-2024-00267
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    March 29, 2024
    Report Date
    July 10, 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 (B)(6) 2024: LOT 2315167: 24 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2023. EXPIRATION DATE: 2028-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON (B)(6) 2024: GMK-SPHERIKA 02.12.E0513FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R E-CROSS (K202022) LOT 2242963: 25 ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA05R FEMORAL COMPONENT SPHERIKA CEMENTED S5R (K211004) LOT 2340179: 15 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2023. EXPIRATION DATE: 2028-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    THE PATIENT CAME IN ON (B)(6) 2024 AND HAD PERMANENT HARDWARE IMPLANTED.

    Description of Event or Problem · 0

    AT ABOUT 2 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
    860045 GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2315167 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention