BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    MDR report key: 8699596 · Received June 14, 2019

    Report

    Report Number
    3005180920-2019-00463
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 18TH 2019 WE RECEIVED THIS ADDITIONAL INFORMATION: DURING THE SURGERY ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON DECIDED TO IMPLANT A FEMORAL COMPONENT AND POLY AND CEMENT THEM TO THE TIBIA TO ACT AS A "SPACER". THE SURGEON ALSO IMPLANTED ANTIBIOTIC BEADS INTO THE PATIENT AND PRESCRIBED THE PATIENT ANTIBIOTICS FOR 6 WEEKS. ON (B)(6) 2019, THE SURGEON REMOVED ALL COMPONENTS FROM THE PATIENT AND PUT IN PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PLEASE LET ME KNOW IF YOU NEED ANY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 JUN 2019: LOT 150409: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L (K140826) LOT. 172747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2017. EXPIRATION DATE: 2022-07-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY (WASHOUT AND POLY SWAP) HAS BEEN PERFORMED ON (B)(4) 2018, 5 MONTHS FROM THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN UNKNOWN, THE COMPLAINT: (B)(4), MDR: 2018-00330 WAS FILED). PRESENTLY THE SECOND REVISION SURGERY HAS BEEN PERFORMED AFTER 1 YEAR AND 1 MONTH FROM THE LAST REVISION DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED THE FEMORAL COMPONENT AND THE INLAY AND IMPLANTED ANTIBIOTIC BEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493762 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L KNEE POLYETHYLENE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 150409 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention