BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE CENTRAL SCREW 6.5X35MM ST/RST

    MDR report key: 15212155 · Received August 11, 2022

    Report

    Report Number
    0001825034-2022-01839
    Event Type
    Injury
    Date Received
    August 11, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677098
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMMON DEVICE NAME: PHX. CONCOMITANT MEDICAL PRODUCTS: COMPREHENSIVE REVERSE 25MM BASEPLATE + ADAPTOR, CAT# 010000589, LOT# 435290; COMPREHENSIVE PRIMARY STEM 11MM MINI, CAT# 113631, LOT# 950540; ARCOM XL 44-36 STD HUMERAL BEARING, CAT# XL-115363, LOT# 249640; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM, CAT# 115310, LOT# 654310; COMPREHENSIVE REVERSE TRAY CO 44MM, CAT# 115370, LOT# 382000; COMPREHENSIVE LOCKING SCREW3.5HEX 4.75X25 ST, CAT# 180552, LOT# 224610; COMPREHENSIVE LOCKING SCREW 3.5HEX 4.75X25 ST, CAT# 180552, LOT# 224610; COMPREHENSIVE NONLOCKING SCREW 3.5HEX 4.75X20 ST, CAT# 180558, LOT# 372940. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 01832; 0001825034 - 2022 - 01833; 0001825034 - 2022 - 01834; 0001825034 - 2022 - 01835; 0001825034 - 2022 - 01837; 0001825034 - 2022 - 01840; 0001825034 - 2022 - 01841; 0001825034 - 2022 - 01842.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING SHOULDER PAIN, INSTABILITY, AND ROM ISSUES APPROXIMATELY SEVEN YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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
    2167423 COMPREHENSIVE REVERSE CENTRAL SCREW 6.5X35MM ST/RST SHOULDER PROSTHESIS SCREW PHX ZIMMER BIOMET, INC. NI 193820 00880304677098

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10