BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    MDR report key: 14641376 · Received June 9, 2022

    Report

    Report Number
    3005180920-2022-00433
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT EARLY INFECTION AFTER PRIMARY CEMENTED TKA REQUIRES REMOVAL OF ALL COMPONENTS. NO REASON TO SUSPECT THAT THE IMPLANTED DEVICES PLAYED A ROLE IN CAUSING THIS ADVERSE EVENT. BATCH REVIEW PERFORMED ON 17 MAY 2022 LOT 2108907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K121416) LOT. 2102536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2021. EXPIRATION DATE: 2026-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 2108282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2021. EXPIRATION DATE: 2026-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT. 2105043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JULY-2021. EXPIRATION DATE: 2026-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AND A HALF AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632090 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R KNEE TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.0412FR 2108907 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention