BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS MOD. TIB. TRAY

    MDR report key: 3051317 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01237
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 6197-9-001, LOT CODE: MJN036, SIMPLEX P WITH TOBRAMYCIN 1 PACK. CAT. NO.: 6478-6-645, LOT CODE: E31SZTRN07, TI DUR REG FLUTED STEM 19X80MM. CAT. NO.: 6478-6-635, LOT CODE: GB1S2TRN34, TI DUR REG FLUTED STEM 17X80MM. CAT. NO.: 75-1-0510, LOT CODE: T05A477, SCORPIO TS DISTAL BLOCK. CAT. NO.: 76-4105R, LOT CODE: K05W1093S2, SCORPIO TS FEM. W/LFIT. CAT. NO.: 75-2-0510, LOT CODE: T05T124, SCORPIO TS POSTERIOR FEM BLOCK. CAT. NO.: 75-2-0510, LOT CODE: T02C678, SCORPIO TS POSTERIOR FEM BLOCK. CAT. NO.: 72-4-5710, LOT CODE: A5NMEA, SCORPIO TS TIB INSERT. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A SCORPIO BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE MEDICAL RECORDS BY A CLINICIAN CONSULTANT CONCLUDED; IN THIS VERY ELDERLY PATIENT WITH MULTIPLE COMPLAINTS OF PAIN IN VARIOUS SITES, AS NOTED BY THE PAIN SERVICE NOTES DURING THE PERIOD OF (B)(6) 2013, THERE DOES NOT APPEAR TO BE A PROSTHETIC COMPONENT RELATED CLINICAL PROBLEM REGARDING THE REVISION RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2007. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. MEDICAL REVIEW COMPLETED ON THE PROVIDED MEDICAL INFORMATION COULD NOT IDENTIFY THE EXACT CAUSE OF THE REPORTED PAIN; HOWEVER THERE IS NO EVIDENCE THE EVENT IS DEVICE RELATED. OPERATIVE REPORTS AND X-RAYS OF THE PRIMARY KNEE SURGERY AS WELL AS ADDITIONAL OFFICE NOTES ARE REQUIRED TO DETERMINE A ROUTE CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WERE RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS IN A GREAT DEAL OF PAIN AND IS CURRENTLY USING A WALKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS IN A GREAT DEAL OF PAIN AND IS CURRENTLY USING A WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152790 SCORPIO TS MOD. TIB. TRAY IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH D7LMRA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other