BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L

    MDR report key: 9416217 · Received December 5, 2019

    Report

    Report Number
    3005180920-2019-01040
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 11, 2019
    Report Date
    May 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826573
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 NOVEMBER 2019. LOT 180925: 25 ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF ACUTE INFECTION. THE SURGEON PERFORMED WASHOUT AND REVISED THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209826 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 180925 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention