BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R E-CROSS

    MDR report key: 18951463 · Received March 21, 2024

    Report

    Report Number
    3005180920-2024-00114
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262324
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER HAVE SENT THE INITIAL REPORT ON MARCH 21ST 2024 IT WAS RECOGNISED THAT THE DATE OF THE EVENT WAS INCORRECT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-MAR-2024 LOT 2110600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2021. EXPIRATION DATE: 2026-09-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: PRELIMINARY INVESTIGATION BASED ON THE PICTURE OF THE REMOVED COMPONENTS REVEALS THAT THE DISTAL SURFACE OF THE COMPONENT LOOKS DAMAGED, PRESENTING 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 TO BODYLOAD PRESSURE AND WAS NOT ENGAGED IN THE TIBIAL TRAY. IT IS LIKELY THAT THE INSERT WAS NOT PROPRELY ENGAGED DURING PRIMARY SURGERY. THERE IS NO EVIDENCE TO SUSPECT THAT THE EVENT WAS RELATED TO A FAULTY DEVICE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ONE YEAR AFTER PRIMARY CEMENTED TKA WITH A MEDIALLY STABILIZED SYSTEM, THE PATIENT FEELS INSTABILITY AND THE SURGEON REOPENS THE JOINT. APPARENTLY HE FOUND A STABLE IMPLANT AND REPLACED THE INSERT ONLY, ADDING 1MM THICKNESS. FROM THE PHOTOGRAPH OF THE EXPLANTED INSERT, IT APPEARS RATHER LIKELY THAT THE INSERT DISSOCIATED FROM THE TRAY, OR THAT IT NEVER REACHED FULL CLIPPING-IN. AS NO RADIOGRAPHS WERE SUPPLIED, WE CANNOT FORMULATE AN OPINION ON THE POSITION OF THE DEVICES. IT IS TO BE PRESUMED THAT DURING REVISION SURGERY AN ADJUSTMENT OF THE SOFT TISSUES WAS PERFORMED, BUT WE HAVE NO DATA. NO FINAL CONCLUSION CAN BE REACHED WITH THE INFORMATION AT HAND. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 21-MAR-2024 GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 2119408 LOT 2119408: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2022. EXPIRATION DATE: 2027-05-04. 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.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE E-CROSS INLAY FROM THE TIBIAL BASEPLATE 1 YEAR AFTER THE PRIMARY SURGERY. THE INLAY HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877245 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2110600 07630971262324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention