BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO-FLEX PS X3 TIB INSERT

    MDR report key: 3748873 · Received April 14, 2014

    Report

    Report Number
    0002249697-2014-01166
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE LOT WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 17-JAN-2006. BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 2004 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING FRACTURED INSERT POSTS. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EVENT WAS CONFIRMED BY RETURN OF THE SUBJECT DEVICE. MATERIAL ANALYSIS INDICATED THE POST FRACTURED IN FATIGUE. THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE FATIGUE FAILURE OF THE POST DUE TO REPEATED CONTACT WITH THE FEMORAL COMPONENT DURING NORMAL USE OF THE DEVICE. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DETERMINED UPON EXAMINATION THAT KNEE WAS UNSTABLE. DECIDED TO REVISE KNEE. REVISION TOOK PLACE ON (B)(6) 2014. UPON EXAMINING THE INSERT 72-25-0912 DURING SURGERY, IT WAS DETERMINED THE POST WAS BROKEN. SURGEON DECIDED TO EXCHANGE THE INSERT WITH A 72-25-0912 LOT CODE #MLA9L2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DETERMINED UPON EXAMINATION THAT KNEE WAS UNSTABLE. DECIDED TO REVISE KNEE. REVISION TOOK PLACE ON (B)(6) 2014. UPON EXAMINING THE INSERT 72-25-0912 DURING SURGERY, IT WAS DETERMINED THE POST WAS BROKEN. SURGEON DECIDED TO EXCHANGE THE INSERT WITH A 72-25-0912, LOT CODE #MLA9L2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227159 SCORPIO-FLEX PS X3 TIB INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH 36865703

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention