BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE GENERAL MIS SET

    MDR report key: 8840208 · Received July 30, 2019

    Report

    Report Number
    3005180920-2019-00645
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630030882890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JULY 2019: LOT 1902049, CODE 11.01002: 20 ITEMS MANUFACTURED AND RELEASED ON 20 MAR 2019. EXPIRATION DATE: 2024-03-06. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. CONCERNING THE SEMI-FINISHED DEVICE SUBJECT OF THIS CASE: CODE 77.11.0063, LOT MAT27910: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE, 5 SIMILAR CASES RECEIVED UP TO NOW (THIS INCLUDED). PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D PROJECT MANAGER: DURING TRIAL FEMORAL POSITIONING, ONE OF THE ARM OF THE FEMORAL IMPACTOR BROKE; THE REASON COULD BE UN EXCESSIVE FORCE APPLIED THROUGH THE HANDLE DURING THE INSTRUMENT TIGHTENING. IN THIS SITUATION THE TWO LATERAL HARMS COULD HAVE BEEN OVER STRESSED REDUCING RESISTANCE DURING IMPACTIONS. ANOTHER FACTOR THAT COULD HAVE CAUSED THE BREAKAGE COULD BE EXCESSIVE LATERAL FORCING TRYING TO REPOSITION IN MEDIO/LATERAL OR FLEXO/RECURVATUM THE FINAL IMPLANT POSITION OR TRYING TO COMPLETE THE IMPLANT POSITIONING USING THIS FEMORAL IMPACTOR EXTRACTOR. THE SURGICAL TECHNIQUE RECOMMENDS TO USE THIS INSTRUMENT ONLY TO POSITION AND CENTERING THE FEMORAL COMPONENT ON THE RESECTED FEMUR BUT TO NOT USE IT FOR FINAL IMPACTIONS. FOR THIS OPERATION THE SURGEON HAS TO USE THE FEMORAL IMPACTOR ASSEMBLED ON THE MULTIFUNCTIONAL HANDLE. HOWEVER, A NEW MODIFICATION REQUEST WAS OPENED TO MANAGE AN INSTRUMENT UPDATE; WITH THIS DESIGN MODIFICATION, THE DISTRIBUTION OF THE FORCES DURING IMPACTIONS WILL BE IMPROVED THANKS TO A BETTER CONGRUENCY BETWEEN FEMORAL IMPACTOR AND FEMORAL COMPONENTS.

    Description of Event or Problem · 1

    WHEN THE SURGEON IMPACTS THE TRIAL FEMORAL COMPONENT, THE FEMORAL IMPACTOR/EXTRACTOR CLAW BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635992 GMK SPHERE GENERAL MIS SET INSTRUMENT FOR KNEE SURGERY LXH MEDACTA INTERNATIONAL SA 1902049 07630030882890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other