BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIGLIDE

    MDR report key: 4091232 · Received June 27, 2014

    Report

    Report Number
    9614209-2014-00057
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    December 1, 2011
    Report Date
    June 27, 2014
    Manufacturer
    CORIN LTD
    Product Code
    HRY
    PMA / PMN Number
    K050764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. DEVICE DETAILS, PT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS TO BE REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    A FIELD UNIGLIDE TWO STAGE REVISION OF THE FEMORAL, TIBIAL AND MENISCAL INSERT COMPONENTS DUE TO INFECTION. THESE WERE REPLACED WITH A SPACER IN (B)(6) 2011 AND THE PT WAS REVISED TO A TKR IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377037 UNIGLIDE UNICONDYLAR KNEE PROSTHESIS HRY CORIN LTD DATA NOT PROVIDED DATA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention TIBIAL OR MENISCAL INSERT COMPONENTS.| DATA HAS NOT BEEN PROVIDED FOR EITHER THE FEMORAL,