BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS TIB INSERT

    MDR report key: 3981796 · Received August 5, 2014

    Report

    Report Number
    0002249697-2014-03002
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2001
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES LISTED IN THIS REPORT: CAT. NO: 7650-2038A, STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG, LOT CODE: SC15938D1. CAT. NO: 77-4007, SCORPIO TS MOD. TIB. TRAY, LOT CODE: D76MHE. CAT. NO: 64786625, TI DUR REG FLUTED STEM 15X80MM, LOT CODE: T1242. CAT. NO: 64786705, TI DUR REG FLUTED STEM14X155MM, LOT CODE: TRN782. CAT. NO: 76-4107R, SCORPIO TS FEM. W/LFIT, LOT CODE: DLYMLD. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MANUFACTURING DATE. AN EVENT REGARDING INFECTION INVOLVING A SCORPIO TS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTIONS WERE NOT PERFORMED AS NO ITEMS WERE RETURNED. A DEVICE HISTORY REVIEW INDICATED THAT THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD REVISION OF RIGHT KNEE DUE TO INFECTION. DOCTOR REMOVED FEMUR, STEM, TIBIA, POLY AND LEFT PATELLA. DOCTOR ALSO ADDED A SPACER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD REVISION OF RIGHT KNEE DUE TO INFECTION. DOCTOR REMOVED FEMUR, STEM, TIBIA, POLY AND LEFT PATELLA. DOCTOR ALSO ADDED A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458122 SCORPIO TS TIB INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 2HVMAE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention