BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 15212114 · Received August 11, 2022

    Report

    Report Number
    0001825034-2022-01835
    Event Type
    Injury
    Date Received
    August 11, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475373
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROCODE: PHX. 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 TRAY CO 44MM CAT# 115370 LOT# 382000, COMPREHENSIVE REVERSE CENTRAL SCREW 6.5X35MM ST/RST CAT# 115397 LOT# 193820, 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 - 01837, 0001825034 - 2022 - 01839, 0001825034 - 2022 - 01840, 0001825034 - 2022 - 01841, 0001825034 - 2022 - 01842.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) -HEAD. 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. 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
    2110821 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI 654310 00880304475373

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10