BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM

    MDR report key: 16032554 · Received December 22, 2022

    Report

    Report Number
    3005180920-2022-00968
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 29, 2022
    Report Date
    March 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862625
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-DEC-2022. LOT: 2002794: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2020. EXPIRATION DATE: 2025-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    REFERENCE OF THE PRODUCT CORRECTED, LOT NOT CHANGED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. ALMOST 2 YEARS AFTER THE PRIMARY TKR, THE JOINT IN UNSTABLE AND THE PATIENT REPORTS A SNAP FEELING WHEN WALKING - NO PAIN. THE SURGEON REPLACES THE INSERT TO A THICKER ONE AND THE PROBLEM SEEMS TO BE SOLVED. THE ROOT CAUSE SHOULD THEREFORE BE DEFINED AS SECONDARY PROGRESSIVE INSTABILITY DUE TO LIGAMENT LAXITY. THIS IS A POSSIBLE DEVELOPMENTAL COMPLICATION AFTER KNEE REPLACEMENTS, BROADLY DESCRIBED IN LITERATURE. IT IS NOT DUE TO A FAULTY DEVICE. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER ALMOST 2 YEARS OF PRIMARY IMPLANTATION DUE TO SNAPPING OF THE KNEE WHILE WALKING. DURING THE REVISION SURGERY THE TIBIAL INSERT HAS BEEN REPLACED WITH A THICKER ONE. FROM VISUAL INSPECTION OF THE EXPLANTED INSERT, NO ANOMALIES CAN BE NOTED. FROM EVENT DESCRIPTION AND VISUAL INSPECTION WE GUESS THE CAUSE OF THE PAIN AND THE REVISION WAS INSTABILITY. FROM VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, REVISION WAS PERFORMED DUE TO KNEE SNAPPING DURING WALKING. NO PAIN WAS REPORTED BY THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE TIBIAL INSERT (14MM) WITH AN INSERT OF THE SAME THICKNESS (14MM), RESTORING THE STABILITY OF THE KNEE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, REVISION WAS PERFORMED DUE TO KNEE SNAPPING DURING WALKING. NO PAIN WAS REPORTED BY THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE TIBIAL INSERT (11MM) WITH A THICKER ONE (14MM), RESTORING THE STABILITY OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2919008 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0114FR 2002794 07630030862625

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention