BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MJS TIBIAL KNEE

    MDR report key: 9770634 · Received February 28, 2020

    Report

    Report Number
    1644408-2020-00165
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 28, 2020
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    UDI-DI
    00190446047827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS DUE TO POLY WEAR AND REPLACEMENT. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 13.9 YEARS APART. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE. THE REVISION SURGERY WAS COMPLETED AS INTENDED AND WITHOUT INCIDENT. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOW THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO POLY WEAR. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THAT THE REPORTED DEVICE WAS DEFECTIVE. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF DO SURGICAL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY: DUE TO POLY WEAR AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232349 MJS TIBIAL KNEE INSERT,TIBIAL#3 MJS ANATOMIC 1 STD. 14X70 JWH ENCORE MEDICAL L.P. T913 00190446047827

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 77-0001-5B, LOT U591