BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    26MM STD V40 TAPER VIT HEAD

    MDR report key: 3150620 · Received June 6, 2013

    Report

    Report Number
    0002249697-2013-01849
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION INCLUDING THE OPERATIVE REPORT AND X-RAYS ARE NEEDED IN ORDER TO COMPLETE THIS INVESTIGATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A BHA, A SURGEON FELT THAT A INNER HEAD WAS TIGHT INTO A CENTRAX. HOWEVER, HE IMPLANTED BOTH DEVICES ON A PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A BHA, A SURGEON FELT THAT A INNER HEAD WAS TIGHT INTO A CENTRAX. HOWEVER, HE IMPLANTED BOTH DEVICES ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250314 26MM STD V40 TAPER VIT HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 42169005

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other