BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM L

    MDR report key: 7494710 · Received May 8, 2018

    Report

    Report Number
    3005180920-2018-00308
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 8, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862649
    PMA / PMN Number
    K140826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 MAY 2018 LOT 170304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2017. EXPIRATION DATE: 2022-03-22 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. GMK-SPHERE REFERENCE (B)(4); TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT 176585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 DECEMBER 2017. EXPIRATION DATE: 2022-12-05 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

    DURING SURGERY THE INSERT WOULD NOT SEAT INTO THE TIBIAL BASEPLATE: A SECONDARY INSERT (LOT 155786) WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336025 TIBIAL INSERT FIXED SPHERE FLEX SIZE5/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 170304 07630030862649

    Patients

    Seq Age Sex Outcome Treatment
    1 Other