BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 21855347 · Received April 17, 2025

    Report

    Report Number
    3005180920-2025-00325
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    April 8, 2025
    Report Date
    June 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716118
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP: - DEVICES NOT AVAILABLE FOR INVESTIGATION. - ALL COMPONENTS REVISED.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 APRIL 2025: LOT 2307482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06/06/2023. EXPIRATION DATE: 23/05/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 7 APRIL 2025: GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 2242030: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02/02/2023. EXPIRATION DATE: 18/01/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT 2244438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30/01/2023. EXPIRATION DATE: 13/01/2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO SIGNS OF INFLAMMATION (SUBQUADRICIPITAL EFFUSION), OF UNKNOWN ORIGIN. PATIENT'S NATURAL PATELLA WAS ALSO RESURFACED. HYPOTHESES REMAIN A POSSIBLE CHONDROLYSIS OF THE PATELLA OR AN ALLERGIC PHENOMENON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776582 GMK TOTAL KNEE SYSTEM GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S5L JWH MEDACTA INTERNATIONAL SA 02.12.KA05L 2307482 07630345716118

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention