BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 16618194 · Received March 27, 2023

    Report

    Report Number
    3005180920-2023-00184
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MARCH 2023: LOT 2116066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2022. EXPIRATION DATE: 2027-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 2109874: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT. 2201059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2022. EXPIRATION DATE: 2027-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. AT ABOUT 4 MONTHS FROM THE PRIMARY THE SURGEON REMOVED THE IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934585 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0005R 2116066 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention