BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28MM +4MM V40 TRIAL HEAD

    MDR report key: 3875352 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02317
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K122853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE OF A TRIAL FEMORAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS WERE RETURNED. A REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NONE WERE PROVIDED. NO FURTHER INFORMATION WAS REQUESTED AS THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO PATIENT FACTORS. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS IT PROPERLY IDENTIFIED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED DEVICE FRACTURE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SALES REP HAS REPORTED ON BEHALF OF THE CUSTOMER, THAT A 28MM -4 TRIAL HEAD ALLEGEDLY BROKE DURING SURGERY. THE SALES REP REPORTED THAT WHEN DISLOCATING AFTER TRIALING WITH HEAD THE TRIAL HEAD CAME OUT BROKEN.

    Description of Event or Problem · 1

    THE SALES REP HAS REPORTED ON BEHALF OF THE CUSTOMER, THAT A 28MM -4 TRIAL HEAD ALLEGEDLY BROKE DURING SURGERY. THE SALES REP REPORTED THAT WHEN DISLOCATING AFTER TRIALING WITH HEAD THE TRIAL HEAD CAME OUT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352736 28MM +4MM V40 TRIAL HEAD INSTRUMENT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other