BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    MDR report key: 15361268 · Received September 6, 2022

    Report

    Report Number
    3005180920-2022-00677
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    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 23-AUG-2022: LOT 2100329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2021. EXPIRATION DATE: 2026-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 23-AUG-2022: GMK-SPHERE 02.12.0311FR TIBIAL INSERT FIXED SPHERE FLEX SIYE 3/11 MM R (K140826) LOT 2009017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 2025-10-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT 2010237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2021. EXPIRATION DATE: 2026-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS EXCEPT THE PATELLA, AND RE-IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561647 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003R 2100329 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention