BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFIT CB PLUG

    MDR report key: 2637645 · Received July 2, 2012

    Report

    Report Number
    1219602-2012-00174
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Report Date
    June 7, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE REVIEW INDICATES THAT TEN PATIENTS WITH A MEAN AGE OF (B)(6) WERE EVALUATED PROSPECTIVELY AT 24 MONTHS' FOLLOW-UP. THE NUMBER OF PLUGS USED FOR EACH PATIENT RANGED FROM 1 TO 4. AT 1-YEAR FOLLOW-UP, THE RESULTS WERE SATISFACTORY IN 8 OF 10 PATIENTS, AND POOR IN 2, ACCORDING TO CLINICAL ASSESSMENT (KOOS, VISUAL ANALOG SCALE, AND SF-36). AT 18 MONTHS OF FOLLOW-UP, ALL PATIENTS EXCEPT ONE COMPLAINED OF PAIN AND KNEE SWELLING. REOPERATION RATE FOR IMPLANT FAILURE AT FINAL FOLLOW-UP WAS 70%. MAGNETIC RESONANCE IMAGING AT FINAL FOLLOW-UP SHOWED A CYLINDRICAL CAVITY OF FIBROUS TISSUE INSTEAD OF SUBCHONDRAL BONE RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFIT CB PLUG TRUFIT CB PLUG MQV SMITH & NEPHEW MANSFIELD MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention