BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 11776858 · Received May 5, 2021

    Report

    Report Number
    1644408-2021-00331
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    PHX
    UDI-DI
    00888912024655
    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 INSTABILITY. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 24 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 DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWS THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS AN NONCONFORMANCE ASSOCIATED WITH THE MAIN PART # 508-00-036, SOCKET, INSERT 36MM STD. RSP HUMERAL WHICH DOCUMENTS THAT OUT OF 40 PARTS LOT 1 ITEM WAS REJECTED AND SCRAPPED DUE TO THE PART ON THE ROUTER. ALL OTHER ITEMS IN THE LOT WERE MET WITH FIT, FORM AND FUNCTION REQUIREMENTS. 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 DEVICES WERE 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, 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 SHOULDER BECAME UNSTABLE, A THICKER POLY WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672846 RSP SOCKET, INSERT 36MM STD. RSP HUMERAL PHX ENCORE MEDICAL L.P 508-00-036 856C2000 00888912024655

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention