BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT 90-SRK-130512 PS SIZE 5 X 12MM (KNEE)

    MDR report key: 8537343 · Received April 22, 2019

    Report

    Report Number
    1226420-2019-00082
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 22, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    JWH
    PMA / PMN Number
    K150496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING AN ORTHO TOTAL KNEE IT WAS REPORTED FROM THE START OF THE CASE, THE SURGEON ASKED FOR A PS POLY TRIAL AND THE ONLY TRIALS BROUGHT IN BY MTS STAFF WERE CR TRIALS. THE WRONG PRODUCT WAS SHIPPED TO THE HOSPITAL. PATIENT WAS UNDER ANESTHESIA AND PREPPED; HOWEVER, THE CASE WAS ABORTED. THERE WAS NO INJURY TO THE PATIENT REPORTED. ADDITIONAL INFORMATION FROM THE HCP REPORTED HE THOUGHT IT WAS DUE TO POOR SOFT TISSUE (COLLATERAL LIGAMENTS) LEADING TO THE IMPLANT 'JUMPING THE POST'. I BELIEVE THAT HCP'S INTENTION WAS TO REMOVE THE IMPLANT POLY INSERT AND REPLACE IT WITH A THICKER ONE. ADDITIONAL INFORMATION REPORTED THE PATIENT REQUIRED A REVISION DUE TO THE PATIENTS LIGAMENTS LOOSENED UP OVER TIME. THE SURGEON ENDED UP PUTTING IN A 14MM POLY (ORIGINALLY A 12MM WAS IN) WHICH TIGHTENED UP SOME MOVEMENT IN THE KNEE DURING RANGE OF MOTION AND THE EXTENSION AND FLEXION GAPS. IT WAS NOTED THE IMPLANT DATE WAS (B)(6) 2018. IT WAS NOTED THE REVISION HAD BEEN SCHEDULED FOR (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329282 INSERT 90-SRK-130512 PS SIZE 5 X 12MM (KNEE) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH MEDTRONIC ADVANCED ENERGY, LLC 90-SRK-130512 XXA17E9

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention