BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

    MDR report key: 8420921 · Received March 14, 2019

    Report

    Report Number
    3005180920-2019-00151
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827167
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 MARCH 2019: LOT 131501: (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) TWO ADDITIONAL ITEMS WERE INVOLVED IN THE COMPLAINT: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM, LOT 141804, (K121416): (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED. GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R, LOT 142546, (K121416): (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO NEEDED A REVISION 4 YEARS AND 6 MONTHS AFTER THE PRIMARY DUE TO INFECTION (THE PATHOGEN IS UNKNOWN). ON THE FOLLOWING DAY THE TIBIAL TRAY, INSERT AND FEMORAL COMPONENT HAVE BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215634 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R KNEE FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 131501 07630030827167

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention