BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 PS TIBIAL INSERT #5 12MM

    MDR report key: 8285950 · Received January 29, 2019

    Report

    Report Number
    0002249697-2019-00364
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 4, 2019
    Report Date
    June 12, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    UDI-DI
    07613327030983
    PMA / PMN Number
    K071991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING REVISION DUE TO MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE INVOLVING A SCORPIO INSERT WAS REPORTED. CONCLUSION: BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION OR ALLEGATION THAT THE DEVICE REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT. A MATERIAL ANALYSIS REPORT (MAR) OF THE RETURNED DEVICE CONFIRMED THAT THE DAMAGE PRESENT ON THE ARTICULATING SURFACE OF THE TIBIAL INSERT WAS CONSISTENT WITH BURNISHING, SCRATCHING, AND THIRD BODY INDENTATIONS; WHICH ARE COMMON DAMAGE MODES OF UHMWPE. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. AS REPORTED THE REVISION SURGERY WAS TAKEN PLACE DUE TO MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE AND X3 PATELLA FRACTURE. THE WHOLE CONSTRUCT WERE REVISED TO ZAN VANGUARD 360 (NON-STRYKER COMPONENTS). A FULL INVESTIGATION IS COMPLETED ON THE SCORPIO PATELLA (PR 1979172) UNDER THE SAME PI. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    ON (B)(6) 2013 TKA PROCEDURE DONE. THE PRODUCTS #81-4406R, #OR-7115-0005, #82-7-0512,#73-20-3508 WERE IMPLANTED IN PATIENT. (B)(6) 2019, PERFORMING TKA RE-REPLACEMENT SURGERY WITH MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE. THE REPLACEMENT IMPLANT IS COMPETITOR 360. IMPLANTED PEG WAS BROKEN AND THE 73-20-3508 X3 PATELLA UNIVERSAL DOME WAS BROKEN ALSO.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 TKA PROCEDURE DONE. THE PRODUCTS #81-4406R, #OR-7115-0005, #82-7-0512,#73-20-3508 WERE IMPLANTED IN PATIENT. ON (B)(6) 2019, PERFORMING TKA RE-REPLACEMENT SURGERY WITH MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE. THE REPLACEMENT IMPLANT IS COMPETITOR 360. IMPLANTED PEG WAS BROKEN AND THE 73-20-3508 X3 PATELLA UNIVERSAL DOME WAS BROKEN ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77094 SCORPIO NRG X3 PS TIBIAL INSERT #5 12MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327030983

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R