BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L

    MDR report key: 18957292 · Received March 22, 2024

    Report

    Report Number
    3005180920-2024-00062
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862564
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MARCH 2024 LOT 2305659: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2023. EXPIRATION DATE: 2028-MAR-22. 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 COMPONENT INVOLVED: GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K0909889) LOT 2318059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2023. EXPIRATION DATE: 2028-SEP-26. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. REVISION SURGERY AFTER ONE MONTH FROM PRIMARY SURGERY DUE TO TIBIAL INSERT DISLOCATION OF A GMK SPHERE IMPLANT. FROM VISUAL INSPECTION OF THE REMOVED COMPONENT, THE INSERT LOOKS DAMAGED IN ITS DISTAL SURFACE IN CONTACT WITH THE TIBIAL BASEPLATE. IT PRESENTS A SORT OF INCISIONS OF THE NEGATIVE SHAPE OF THE TIBIAL BASEPLATE; THESE HAVE BEEN MOST LIKELY CAUSED BY THE EDGES OF THE LATERAL PROFILE OF THE BASEPLATE WHEN THE INSERT UNDERWENT BODY LOAD PRESSURE AND WAS NOT ENGAGED IN THE TIBIAL TRAY. LOOKING ALSO AT THE POST-PRIMARY X-RAYS, WE CAN NOTICE THAT THE INSERT WAS LIKELY ALREADY DISENGAGED FROM THE BASEPLATE RIGHT AFTER THE SURGERY (AND SO PROBABLY NEVER ENGAGED). IN FACT, THE DISTANCE BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL BASEPLATE SEEMS TOO HIGH TO REPRESENT THE THICKNESS OF THE INSERT IF PROPERLY ENGAGED INTO THE BASEPLATE. THERE IS NO REASON TO SUSPECT THAT THE EVENT WAS CAUSED BY A FAULTY DEVICE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. PARTIAL REVISION SURGERY A FEW WEEKS AFTER PRIMARY CEMENTED TKA. THE REASON FOR THE REVISION WAS INSERT DISSOCIATION FROM THE BASEPLATE. IN FACT, FROM THE POSTOPERATIVE RADIOGRAPH, IT APPEARS THAT THE INSERT WAS ALREADY DISLOCATED AT THAT TIME, AND THEREFORE IT'S LEGITIMATE TO HYPOTHESIZE THAT IT NEVER GOT FULLY CLIPPED IN. THE INSERT IS MECHANICALLY DAMAGED BY IMPROPER LOADING; THEREFORE, AN EXHAUSTIVE DIMENSIONAL CHECK CANNOT BE PERFORMED WITH CONCLUSIVE RESULTS. WE DO NOT THINK THAT A PLAUSIBLE ROOT CAUSE FOR THIS EVENT CAN BE SOUGHT IN THE CLINICAL PERFORMANCE OF THE IMPLANT.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE INLAY FROM THE TIBIAL BASEPLATE 1 MONTH AFTER THE PRIMARY SURGERY. THE INLAY HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553098 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2305659 07630030862564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention