BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 19527700 · Received June 13, 2024

    Report

    Report Number
    3005180920-2024-00415
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 13, 2024
    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

    BATCH REVIEW PERFORMED ON 24 MAY 2024 LOT 168738: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2017. EXPIRATION DATE: 2022-03-02. 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. PRELIMINARY ANALYSIS PERFORMED BY R&D PROJECT MANAGER FROM THE ANALYSIS OF THE PICTURES OF THE EXPLANTED COMPONENTS, NO ANOMALIES CAN BE NOTED ON THE IMPLANTS. NO RESIDUAL CEMENT CAN BE IDENTIFED ON THE DISTAL SURFACE OF TIBIAL BASEPLATE AND ON THE INTERNAL SURFACE OF THE FEMORAL COMPONENT. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT CAN BE RELATED TO MULTIPLE FACTORS, NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, TIME, PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE) ON THE ARTICULAR SURFACES OF THE TIBIAL INSERT, NO SIGNS OF WEAR OR DELAMINATION CAN BE NOTED. THERE IS NO EVIDENCE TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE. ADDIITONAL INVOLVED IMPLANT BATCH REVIEW PERFORMED ON 24 MAY 2024 ON GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 170446 LOT 170446: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2017. EXPIRATION DATE: 2022-03-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 6 YEARS AND 10 MONTHS POST PRIMARY DUE TO TIBIAL AND FEMORAL COMPONENTS LOOSENING. NO CEMENT ON FOUND ON THE IMPLANT DURING THE REVISION. THE PATIENT WAS INSTABLE AND THERE WAS DEVICES MALALINGNMENT. GMK REVISION SYSTEM IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766455 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 168738 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention