BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAGLIDE+ KNEE SYSTEM

    MDR report key: 5124595 · Received September 30, 2015

    Report

    Report Number
    9614209-2015-00053
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    October 22, 2013
    Report Date
    September 28, 2015
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    JWH
    PMA / PMN Number
    K000232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. THE INSTRUMENT WAS RETURNED TO CORIN AND REVIEWED ALONG WITH THE DEVICE MANUFACTURING RECORDS. THE INVESTIGATION CONFIRMED THAT THE INSTRUMENTAL WAS FOUND TO MEET SPECIFICATION AND FUNCTIONALITY. 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

    IT WAS REPORTED THAT DURING SURGERY, THE IM ROD MODULAR T-HANDLE WAS BEING USED, WHEN BALL BEARINGS FROM THE INSTRUMENT BECAME LOOSE AND FELL INTO THE PATIENT. THE BALL BEARINGS WERE IMMEDIATELY RETRIEVED. THE PATIENT WAS UNAFFECTED AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644414 ROTAGLIDE+ KNEE SYSTEM KNEE PROSTHESIS JWH CORIN MEDICAL, LTD. 255.202

    Patients

    Seq Age Sex Outcome Treatment
    1