BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L

    MDR report key: 10147230 · Received June 12, 2020

    Report

    Report Number
    3005180920-2020-00321
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862656
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MAY 2020: LOT 168321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2017. EXPIRATION DATE: 2022-02-07. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 MAY 2020: GMK-REVISION 02.07.0514SCF FIXED TIBIAL INSERT SC SIZE 5/14MM (K103170) LOT. 146769. LOT 146769: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED IN RIGHT KNEE WITH COMPETITOR PRODUCTS. THEN REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2016 AND REVISION INSERT WAS IMPLANTED. LEFT KNEE PRIMARY SURGERY WAS PERFORMED ON THE (B)(6) 2018, SPHERE INSERT WAS USED. NOW THE PATIENT CAME IN DUE TO SIGNS OF INFECTION IN BOTH KNEES AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A BILATERAL I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614593 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0513FL 168321 07630030862656

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention