BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 12046966 · Received June 22, 2021

    Report

    Report Number
    1644408-2021-00570
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912024648
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INFECTION. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 5 YEARS AND 9 MONTHS 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 RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMR) ASSOCIATED WITH THE PRODUCTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THE ROOT CAUSE OF THIS COMPLIANT WAS A REVISION SURGERY DUE TO AN INFECTION. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. 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 POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION 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 · 1

    REVISION SURGERY - DUE TO INFECTION. NO PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942775 RSP SOCKET, INSERT 32MM STD. RSP HUMERAL PHX ENCORE MEDICAL L.P. 508-00-032 855C1915 00888912024648

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 508-32-103 LOT 864C2062| 510-00-008 LOT 979F1182