BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL MIS SPHERE INSTRUMENT SET

    MDR report key: 8691478 · Received June 12, 2019

    Report

    Report Number
    3005180920-2019-00454
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630030882890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 JUN 2019: GENERAL MIS SPHERE INSTRUMENT SET REF 11.01002, LOT 1901032: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-02-18. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD, WITHOUT ANY OTHER SIMILAR EVENT REGISTERED. CONSIDERING THE SPECIFIC COMPONENT FEMORAL IMPACTOR/ EXTRACTOR, REF77.11.0063, LOT MAT27910 ((B)(4) PIECES): THIS IS THE 4TH CASE RECEIVED FOR THE BREAKAGE OF THE CENTRAL BODY. THE OTHER COMPLAINTS ARE: (B)(4) [MDR2019-00448], (B)(4) AND (B)(4). PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE BREAKAGE OF A PIECE OF THE FEMORAL IMPACTOR EXTRACTOR HEAD COULD HAVE BEEN CAUSED DUE SEVERAL FACTORS SUCH AS AN EXCESSIVE TIGHTENING FORCE APPLIED DURING FEMORAL IMPLANT FIXATION, EXCESSIVE FORCE/IMPACTIONS TRYING TO ADJUST THE TRIAL FEMORAL POSITIONS (ML AND FLEXUM POSITIONING).

    Description of Event or Problem · 1

    DURING THE PRIMARY KNEE SURGERY AND WHILE IMPACTING THE FEMORAL COMPONENT, THE GMK EFFICIENCY FEMORAL IMPACTOR/EXTRACTOR BROKE AT THE CENTRAL PART. NO BROKEN FRAGMENTS FELL INTO THE PATIENT'S SURGICAL WOUND AND THERE WAS ONE MINUTE DELAY IN THE CASE. THE SURGEON SWAPPED TO CONVENTIONAL INSTRUMENTATION TO COMPLETE THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487428 GENERAL MIS SPHERE INSTRUMENT SET SURGICAL INSTRUMENT FOR KNEE SURGERY LXH MEDACTA INTERNATIONAL SA 1901032 07630030882890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other