BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOGRAM KNEE BALANCER

    MDR report key: 1830057 · Received September 7, 2010

    Report

    Report Number
    9610726-2010-00280
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORT THAT THE HEAD OF THEATRE, REPORTS VIA OUR SALES REPRESENTATIVE THAT THE HANDLE BROKE. SHE STATED FURTHER MORE THAT THE HANDLE WAS RECEIVED ON (B)(6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOGRAM KNEE BALANCER INSTRUMENT LXH STRYKER ORTHOPAEDICS LIMERICK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other