BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 15303789 · Received August 26, 2022

    Report

    Report Number
    1644408-2022-01138
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912144582
    PMA / PMN Number
    K100741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: 01/13/2027 (13-JAN-2027): THE REASON FOR THIS REVISION SURGERY WAS DUE TO UNSTABLE JOINT. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 38 DAYS APART. 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 DEVICES WERE 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 COMPONENTS 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 UNSTABLE JOINT. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THAT 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 SHORT TIME BETWEEN PREVIOUS AND REVISION SURGERY, IT IS POSSIBLE THAT THE EVENT MAY HAVE OCCURRED DUE TO LACK OF POST-OPERATIVE CARE, PATIENT NONCOMPLIANCE WITH MEDICAL INSTRUCTIONS OR INCORRECT IMPLANT SELECTION, PROLONGED OVERHEAD ACTIVITIES, 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 IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - THE PATIENT'S JOINT WAS UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218809 RSP RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS PHX ENCORE MEDICAL L.P. 509-00-436 386P1214A 00888912144582

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention