BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 16831490 · Received April 28, 2023

    Report

    Report Number
    3005180920-2023-00320
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    March 31, 2023
    Report Date
    April 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 APRIL 2023. LOT 2112921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2021. EXPIRATION DATE: 2026-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: ONE YEAR AFTER PRIMARY CEMENTED TKA IN AN OVERWEIGHT PATIENT, DISCOMFORT AND PAIN ARE REPORTED AND A SURGEON DIFFERENT FROM THE PRIMARY IMPLANTER PERFORMS A TOTAL REVISION. THE INDEX SURGERY ENDED WITH A FEMORAL COMPONENT INTERNALLY ROTATED, A SIGNIFICANTLY SLANTED TIBIAL TRAY BUT WE HAVE NO IMAGES THAT CAN HELP TO RECONSTRUCT THE ORIGIN OF THESE CHOICES. IT CAN BE SURMISED THAT THIS POSITION OF THE COMPONENTS MAY BE AT THE ORIGIN OF THE PAIN REPORTED BY THE PATIENT. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE FEMUR WAS TOO INTERNALLY ROTATED AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THE DISLOCATION OF NATURAL PATELLA. THE NATURAL PATELLA WAS NOT RESURFACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476433 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0023R 2112921 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention