BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW

    MDR report key: 20321584 · Received September 27, 2024

    Report

    Report Number
    0001825034-2024-02287
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    May 15, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677135
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT IS UNKNOWN WHICH PERIPHERAL SCREW FRACTURED DURING THE EVENT. THERE ARE THREE (3) POSSIBILITIES LISTED BELOW: 180550 (918160). 180551 (372630). 180551 (372630). D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 110032430 (65255617) 115394 (383530R) 180551 (372630) 180551 (372630) ASSOCIATED MEDICAL PRODUCTS, PART (LOT): 113630 (64909774) 405800 (246800) 405800 (246900) 110030777 (65398250) 110031399 (65411984) 110031427 (65838110) 20-8090-004-01 (66002321) G2: FOREIGN - THE EVENT OCCURRED IN AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED LOOSENING AND SCREW FRACTURE EVENTS ARE CONFIRMED BY THE PROVIDED X-RAYS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL ANATOMIC ALIGNMENT OF THE REVERSE-TYPE LEFT SHOULDER ARTHROPLASTY WITH SUBSEQUENT LOOSENING AND SUPERIOR MIGRATION OF THE GLENOID IMPLANT AND A FRACTURED SCREW. BONE QUALITY IS OSTEOPENIC. OPERATIVE NOTES WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BASEPLATE LOOSENING FROM THE GLENOID FOLLOWING AN INITIAL ARTHROSCOPY PROCEDURE. THE SURGEON INDICATED THE PATIENT'S ANATOMY, WITH VERY LITTLE BONE IN THE GLENOID, LIKELY CAUSED THE FAILURE. IMAGING CONFIRMED THIS LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS LATER. ADDITIONALLY, ONE (1) OF THE PERIPHERAL SCREWS WAS FOUND TO BE FRACTURED DURING RADIOGRAPH EVALUATION. A FUTURE REVISION IS PLANNED ON AN UNKNOWN DATE. NO OTHER INTERVENTIONS OR HARMS HAVE BEEN REPORTED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432811 COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 918160 00880304677135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other H11.