BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS RESURFACING PATELLA Ø39 MM

    MDR report key: 8064119 · Received November 13, 2018

    Report

    Report Number
    3005180920-2018-00887
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 29, 2017
    Report Date
    November 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030846564
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEW COMPONENTS IMPLANTED ON (B)(6) 2017 ARE: FEMUR STANDARD CEMENTED, REF 3010.204G LOT N°157130. INSERT STANDARD 3040.0409 LOT N° 130989. TIBIAL TRAY 3031.0204 LOT N° 171280. BATCH REVIEW PERFORMED ON 13 NOVEMBER 2018: LOT 132455: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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. NOTE: THIS COMPONENT (PATELLA RESURFACING) WAS NOT REVISED.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PAIN DUE TO LUXATION OF THE PATELLA NOTICED AFTER RADIOLOGICAL EXAMINATION DONE 17 DAYS AFTER PRIMARY. INSERT, FEMORAL AND TIBIAL COMPONENTS IMPLANTED IN (B)(6) 2016 WERE REVISED. THE PATELLA WAS LEFT IN PLACE. NOTE: EVENT HAPPENED IN (B)(6) 2017 AND NOTIFIED IN OCTOBER 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905046 EVOLIS RESURFACING PATELLA Ø39 MM KNEE PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 132455 07630030846564

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention