BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 12005705 · Received June 15, 2021

    Report

    Report Number
    1644408-2021-00546
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    PHX
    UDI-DI
    00888912144391
    PMA / PMN Number
    K112069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS BASEPLATE CENTRAL SCREW BROKE IN HALF. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 1 YEAR AND 2 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 COMPLAINT WAS A REVISION SURGERY DUE TO BASEPLATE CENTRAL SCREW BROKE IN HALF. 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, 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.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO BASEPLATE CENTRAL SCREW BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893835 RSP RSP BASEPLATE, 30MM, W/P2 COATING PHX ENCORE MEDICAL LP 508-32-204 769P1737 00888912144391

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 506-03-114 LOT 831C1702| 506-03-122 LOT 833C1600| 506-03-130 LOT 835C1640| 506-03-130 LOT 835C1643| 508-32-101 LOT 862C3045| 509-00-032 LOT 377P1513| 530-14-108 LOT 415T1251