BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPOWR VVC KNEE

    MDR report key: 11984323 · Received June 11, 2021

    Report

    Report Number
    1644408-2021-00561
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    JWH
    UDI-DI
    00190446269984
    PMA / PMN Number
    K180930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 38 DAYS APART. INITIAL OR PROLONGED HOSPITALIZATION WAS REQUIRED. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS NO NON-CONFORMING MATERIAL REPORT (NCMR) 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 INSTABILITY. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICE WAS DEFECTIVE. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE EVENT. DUE TO THE SHORT TIME BETWEEN THE PREVIOUS AND THE REVISION SURGERY, IT IS POSSIBLE THAT THE EVENT MAY HAVE OCCURRED DUE TO LACK OF POST-OPERATIVE CARE, PATIENT NONCOMPLIANCE WITH MEDICAL INSTRUCTIONS, IMPROPER SURGICAL TECHNIQUE, PATIENT ACTIVITIES OR TRAUMA. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT WAS EXPERIENCING INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877424 EMPOWR VVC KNEE EMPOWR VVC KNEETM TIBIAL INSERT, SIZE 7, 14MM JWH ENCORE MEDICAL LP 346-14-707 449V1025 00190446269984

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R