BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY PFL OXINIUM TROCHLEAR COMPONENT

    MDR report key: 8161556 · Received December 13, 2018

    Report

    Report Number
    1020279-2018-02782
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 16, 2018
    Report Date
    June 6, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICES WERE RETURNED AND EVALUATED. A LAB ANALYSIS CONDUCTED DURING THIS INVESTIGATION NOTED THAT DEVICES SHOWED WEAR AND DEFORMATION OF THE PATELLA AND FRACTURES OF BOTH THE PATELLOFEMORAL AND THE HINGE. SEM ANALYSIS FOUND THAT THE FRACTURE OF THE PFJ LIKELY INITIATED ON THE ANTERIOR SURFACE AND PROPAGATED TOWARDS THE POSTERIOR AREA. THE FRACTURE OF THE HINGE LIKELY INITIATED AT THE DISTAL REGION AND PROPAGATED TOWARDS THE PROXIMAL REGION. THE INSERT SHOWED SIGNS OF WEAR, SCRATCHING, AND INDENTIONS WHICH COULD HAVE BEEN CAUSED BY EXPLANTATION. THE CAUSES OF THE WEAR AND DISCOLORATION OF THE PATELLA, FRACTURE OF THE PFJ, AND REMOVED MATERIAL FROM THE PFJ COULD NOT BE IDENTIFIED FROM THIS INVESTIGATION. ADDITIONALLY, ALL OF THE COMPONENTS OF THE LEGION HINGE KNEE SYSTEM WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, THE CAUSES OF FAILURE COULD NOT BE DETERMINED. OUR INVESTIGATION INCLUDING A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF THE COMPLAINT HISTORY FOUND NO PRIOR COMPLAINTS FOR THIS FAILURE MODE WITH THE SAME BATCH NUMBER. OUR CLINICAL ANALYSIS NOTED THAT BASED ON THE PROVIDED X-RAY IMAGES, THE ROOT CAUSE COULD NOT BE CONCLUDED AND IT IS UNKNOWN IF THE SIMULTANEOUS USE OF THE COMPONENTS WHICH ARE NOT INDICATED TO BE USED TOGETHER HAD AN IMPACT. HOWEVER, THE REPORTED INTRA-OP FINDINGS (SEVERELY WORN PATELLAR PE/EXPOSED RING AND BROKEN PFJ COMPONENT) WERE LIKELY CONTRIBUTING FACTORS TO THE PATIENT¿S SYMPTOMS AND REPORTED METALLOSIS. IT IS UNKNOWN WHY THERE WAS A 2 MONTH DELAY IN THE SCHEDULED AND ACTUAL REVISION DATE AND IF TRAUMA HISTORY WAS INVOLVED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN JOURNEY PFL OXINIUM TROCHLEAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002251 JOURNEY PFL OXINIUM TROCHLEAR COMPONENT PROSTHSIS, KNE, PATELLOFEMOROTIBIAL, SMI-CONSTRAIND, CMNTED, POLYMER/MTAL/POLYMR JWH SMITH & NEPHEW, INC. 10CM10660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 71420576 / 09DM18165| PART NUMBER 71421686 / LOT NUMBER 16JTM0036