BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 11694746 · Received April 20, 2021

    Report

    Report Number
    1644408-2021-00301
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    PHX
    UDI-DI
    00888912024648
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS BONE SPURS HAD CAUSE SOFT TISSUE DAMAGE/PAIN. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 1 YEAR AND 2 WEEKS APART. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THAT THE REPORTED COMPONENT 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 BONE SPURS HAD CAUSE SOFT TISSUE DAMAGE/PAIN. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICE WAS DEFECTIVE. NO OTHER 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 AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT PRESENTED 1 YEAR POST OPERATION, BONE SPURS HAD CAUSE SOFT TISSUE DAMAGE/PAIN. SURGEON REPLACED POLY WITH SEMI CONSTRAINED DUE TO THE BONE SPUR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593605 RSP SOCKET, INSERT 32MM STD. RSP HUMERAL PHX ENCORE MEDICAL LP 508-00-032 855C2272 00888912024648

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R