BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 36MM

    MDR report key: 22077307 · Received May 23, 2025

    Report

    Report Number
    0001825034-2025-01489
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475779
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B5 THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED PRODUCTS WITH BIOLOGICAL DEBRIS ON THEM. HOWEVER, AS THE PRODUCTS WERE NOT RETURNED, FURTHER ANALYSIS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. IT WAS INDICATED THAT ADDITIONAL GLENOID BONE REMOVAL WAS NECESSARY ON REVISION OF THE PRODUCTS. THIS WAS NOT COMPLETED ON THE INITIAL PROCEDURE DUE TO PREVIOUS BONE FRACTURE. IT IS UNKNOWN IF THE INCOMPLETE BONE REMOVAL IN THE INITIAL PROCEDURE CONTRIBUTED TO THE DISLOCATION. AS SUCH, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH 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 EVENT IS RECORDED BY ZIMMER BIOMET UNDER: (B)(4). G2: COUNTRY EVENT OCCURRED IN: AUSTRALIA. D10 NARRATIVE: ITEM: UNKNOWN HUMERAL BEARING. LOT: UNKNOWN. H6: COMPONENT CODE: PROPOSED CODE: MECHANICAL (G04)- HEAD. THE PRODUCT WILL NOT BE EVALUATED BY ZIMMER BIOMET AS IT WAS NOT RETURNED BY THE HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROSCOPY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS HARM/INJURY TO THE PATIENT AS THE PATIENT HAD TO UNDERWENT ADDITIONAL SURGICAL/MEDICAL INTERVENTION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515097 COMP RVSR SHLDR GLNSP +3 36MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. J7804526 00880304475779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.