BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERIKA CEMENTLESS

    MDR report key: 21227337 · Received January 24, 2025

    Report

    Report Number
    3005180920-2024-01173
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345799289
    PMA / PMN Number
    K223548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 JANUARY 2025: LOT 2408332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19/07/2024. EXPIRATION DATE: 04/07/2029. 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 REVISED: BATCH REVIEWS PERFORMED ON 23 JANUARY 2025: GMK-SPHERIKA 02.12.E0112FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 1L - 12MM (K202022) LOT 2102423: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/05/2021. EXPIRATION DATE: 20/04/2026. 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 02.12.3D01L GMK 3DMETAL TIBIAL TRAY SIZE 1L (K221850) LOT 2311627: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04/10/2023. EXPIRATION DATE: 12/09/2028. 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. ROOT CAUSE: THE ROOT CAUSE OF THE OBSERVED EVENT IS PATIENT'S LIGAMENT LOOSENESS, AS REPORTED BY THE SURGEON. THE REASON FOR LIGAMENT DEGENERATION IS UNKNOWN BUT THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE FEMUR FROM THE TIBIAL INSERT DUE TO LIGAMENT LOOSENESS. ABOUT 7 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT'S REVISION SURGERY INCLUDED REVISING THE FEMUR, TIBIA, AND TIBIAL INSERT COMPONENTS AND GMK REVISION COMPONENTS WERE THEN IMPLANTED AND A SEMI-CONSTRAINED INSERT WAS USED. NO TRAUMATIC EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663456 GMK SPHERIKA CEMENTLESS GMK-SPHERIKA GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S1+L MBH MEDACTA INTERNATIONAL SA 02.12.KA171L 2408332 07630345799289

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention