BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 PS TIBIAL INSERT #9 12MM

    MDR report key: 5769653 · Received July 5, 2016

    Report

    Report Number
    0002249697-2016-02176
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    February 14, 2016
    Report Date
    June 9, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SCORPIO NRG PS FEMORAL #9 RIGHT; CAT# 81-4409R; LOT# MMN61N. SERIES 7000 STANDARD TIBIA; CAT# 7115-0009; LOT# 88816Y. SCORPIO U-DOME X3 PATELLA; CAT# 73-20-3910; LOT# J48M. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. THIS EVENT WAS REPORTED VIA CLINICAL OUTCOMES REPORTING STUDIES. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOOD WORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PATIENT HAD AN INDEX ON (B)(6) 2015. THE PATIENT DEVELOPED DJI, AND IS NOW REVISED. ONLY A POLY EXCHANGE.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PATIENT HAD AN INDEX ON (B)(6) 2015. THE PATIENT DEVELOPED DJI, AND IS NOW REVISED. ONLY A POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422879 SCORPIO NRG X3 PS TIBIAL INSERT #9 12MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH MNE9PW

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention