BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIVATE REVERSE SHOULDER

    MDR report key: 12005664 · Received June 15, 2021

    Report

    Report Number
    1644408-2021-00533
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    PHX
    UDI-DI
    00888912168304
    PMA / PMN Number
    K141990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS STEM LOOSENING AND POSSIBLE INFECTION. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 3 YEARS AND 10 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 STEM LOOSENING AND POSSIBLE 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 ALSO 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 AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS AN INFECTION. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 3 YEARS AND 10 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 AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - STEM SEEMED TO BE LOOSE ON FOLLOW UP. POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893819 ALTIVATE REVERSE SHOULDER ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108MM PHX ENCORE MEDICAL LP 530-08-108 406T1136 00888912168304

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 508-32-103 LOT 864C2601| 509-00-032 LOT 377P1252