BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 12852078 · Received November 22, 2021

    Report

    Report Number
    3005180920-2021-00919
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 28, 2021
    Report Date
    January 25, 2022
    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

    ON (B)(6) 2022 IT WAS NOTICED THAT THERE WAS AN ERROR IN THE BATCH REVIEW OF THE INSERT WHICH WAS REPORTED IN THE INITIAL REPORT. HERE BELOW YOU CAN FIND THE CORRECTED BATCH REVIEW. GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K140826) LOT 2005770 BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 2005770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2020. EXPIRATION DATE: 2025-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 NOVEMBER 2021: LOT 2010168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2021. EXPIRATION DATE: 2026-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 02 NOVEMBER 2021: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 2102521: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2021. EXPIRATION DATE: 2026-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K140826) LOT 2005770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2020. EXPIRATION DATE: 2025-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752298 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.12.0005R 2010168 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention