BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MGRM KNEE BALANCER HEIGHT GDE

    MDR report key: 3092231 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01515
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTRUMENT FRACTURE INTRA-OPERATIVELY INVOLVING A MONOGRAM KNEE BALANCER HEIGHT GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED BECAUSE THE DEVICE WAS DISCARDED. DEVICE HISTORY REVIEW SHOWS THAT HERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW SHOW THAT THERE HAS BEEN ONE OTHER EVENT FOR THE REPORTED LOT. PR 84052 CONCLUDED THAT THE EXACT ROOT CAUSE OF THE DEVICE FRACTURE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE IMPLANT KNEE BALANCER HEIGHT GUIDE BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE IMPLANT KNEE BALANCER HEIGHT GUIDE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194449 MGRM KNEE BALANCER HEIGHT GDE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SLEB438D

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization