BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR EXTRACTOR

    MDR report key: 3214023 · Received July 9, 2013

    Report

    Report Number
    0002249697-2013-02239
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    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 DURING A REVISION OF AN INFECTED KNEE THE TIBIAL IMPACTOR BROKE DURING SURGERY. CAUSED NO DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF AN INFECTED KNEE THE TIBIAL IMPACTOR BROKE DURING SURGERY. CAUSED NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313750 BASEPLATE IMPACTOR EXTRACTOR INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N3C30

    Patients

    Seq Age Sex Outcome Treatment
    1 Other