BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MGRM KNEE BALANCER HEIGHT GDE

    MDR report key: 2011756 · Received February 14, 2011

    Report

    Report Number
    9610726-2011-00033
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 1, 2011
    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
    OTHER

    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 REPORTED THAT ITEM BROKE AFTER ABOUT 6-8 SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MGRM KNEE BALANCER HEIGHT GDE INSTRUMENT LXH STRYKER ORTHOPAEDICS LIMERICK NA SLEB244B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other