BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE GENERAL SET

    MDR report key: 8673856 · Received June 6, 2019

    Report

    Report Number
    3005180920-2019-00448
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 9, 2019
    Report Date
    June 6, 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 (B)(6) 2019: GMK SPHERE GENERAL SET, REF 11.01002, LOT 1901027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT (SAME ISSUE, DIFFERENT LOT): GMK SPHERE GENERAL SET, REF 11.01002, LOT 1810920: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2024-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CONSIDERING THE SPECIFIC COMPONENT FEMORAL IMPACTOR/ EXTRACTOR, REF77.11.0063, LOT MAT26932 ((B)(4) PIECES): THIS IS THE 2ND CASE RECEIVED FOR THE BREAKAGE OF THE CENTRAL BODY. THE OTHER COMPLAINT IS [(B)(4)]. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FROM THE VISUAL INSPECTION IT IS NOT POSSIBLE TO IDENTIFY THE REAL CAUSE OF THE BREAKAGE BECAUSE OF THE LACK OF THE BROKEN PART. WE CAN IMAGINE THAT THE BREAKAGE COULD BE HAPPENED DUE TO EXCESSIVE TIGHTENING FORCE APPLIED DURING FEMORAL IMPLANT FIXATION AND, AS REPORTED ON THE COMPLAINT FORM, THE SURGEON TRIED TO ADJUST THE FLEXION OF THE FEMORAL COMPONENT.

    Description of Event or Problem · 1

    WHEN THE SURGEON IMPACTS THE TRIAL FEMORAL COMPONENT, TWO FEMORAL IMPACTOR BROKE (CENTRAL BODY). THE REASON FOR THE BREAKAGE IS THAT THE FORCE WAS APPLIED TO CORRECT THE FLEXION OF THE TRIAL FEMORAL COMPONENT. THE SURGERY WAS COMPLETED WITH ANOTHER COMPANY'S INSTRUMENT WHICH WAS STORED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470135 GMK SPHERE GENERAL SET SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 1901027 07630030882890

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other