BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 12055232 · Received June 23, 2021

    Report

    Report Number
    1644408-2021-00606
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    PHX
    UDI-DI
    00888912024754
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS MALPOSITIONING AND PAIN. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 5 YEARS AND 3 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 AND SHOWED NO NON-CONFORMING MATERIAL REPORTS (NCMR) ASSOCIATED WITH THE MAIN CONTRIBUTOR COMPONENT LISTED IN THE COMPLAINT. 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 COMPLAINT WAS A REVISION SURGERY DUE TO MALPOSITIONING AND PAIN. 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. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS POOR BONE DENSITY, PROLONGED OVERHEAD ACTIVITIES, INADEQUATE SOFT TISSUE SUPPORT, PATIENT ACTIVITIES OR TRAUMA. 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.

    Additional Manufacturer Narrative · 1

    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 - MALPOSITIONING OF THE ORIGINAL BASEPLATE CAUSED IMPINGEMENT OF SHOULDER RANGE OF MOTION WHICH LEAD TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944132 RSP BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM PHX ENCORE MEDICAL LP 508-32-104 866C2067 00888912024754

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 506-03-122 LOT 833C1234| 506-03-126 LOT 834C1239| 506-03-126 LOT 834C1249| 506-03-126 LOT 834C1254| 508-00-432 LOT 918F1926| 508-32-103 LOT 864C2223| 530-08-108 LOT 406T1017| 506-03-122 LOT 833C1234| 506-03-126 LOT 834C1239| 506-03-126 LOT 834C1249| 506-03-126 LOT 834C1254| 508-00-432 LOT 918F1926| 508-32-103 LOT 864C2223| 530-08-108 LOT 406T1017