BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM

    MDR report key: 4123261 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03633
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    April 14, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT:SCORPIO NRG PS FEMORAL #7 RIGHT; CAT # 81-4407R; LOT# MLA2JY.SERIES 7000 STANDARD TIBIA; CAT # 7115-0005; LOT# MMRAJP.SCORPIO U-DOME X3 PATELLA; CAT # 73-20-3308; LOT# LV88.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: IRRIGATION AND DEBRIDEMENT FOLLOWING PRIMARY THA. LINER EXCHANGE.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: IRRIGATION AND DEBRIDEMENT FOLLOWING PRIMARY THA. LINER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602476 SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMLHMM

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention