BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE

    MDR report key: 23596162 · Received November 19, 2025

    Report

    Report Number
    0001825034-2025-03704
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    January 20, 2021
    Report Date
    November 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475779
    PMA / PMN Number
    K080642
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM#: 211215; LOT#: 261090, ITEM#: 211239; LOT#: 237200, ITEM#: 110032410; LOT#: 64362991, ITEM#: 110031399; LOT#: 64500139, ITEM#: 110031424; LOT#: 64336641, ITEM#: 211228; LOT#: 005970, ITEM#: 211228; LOT#: 978020. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: TENDONITIS IS THE INFLAMMATION OR IRRITATION OF THE TENDONS AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE AND PRESSURE TO THE BURSAE. SYMPTOMS THE PATIENT CAN EXPERIENCE, PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. THIS CAN IMPACT THE PATIENTS¿ ABILITY TO USE THE JOINT TO THEIR FULL POTENTIAL. PATIENT CAN EXPERIENCE A DECREASE WITH OVERALL ADLS, ROM OF THE JOINT, DECREASE IN QUALITY OF LIFE, AS WELL AS INCREASING THE NEED FOR POSSIBLE OVER THE COUNTER (OTC) MEDICATIONS FOR SWELLING AND PAIN CONTROL. TREATMENT FOR TENDONITIS CAN CONSIST OF, OTC MEDICATIONS, SUCH AS TYLENOL AND ANTI-INFLAMMATORIES, PRESCRIBED PAIN MEDICATIONS, PHYSICAL THERAPY, REST, ICE, ELEVATING THE AFFECTED JOINT AND STEROID INJECTIONS. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. IF ANY FURTHER INFORMATION 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 THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AND TWO (2) MONTHS AGO AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, THE PATIENT DEVELOPED TENDONITIS APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND WAS TREATED WITH STEROID INJECTIONS AND PHYSICAL THERAPY. THE EVENT WAS NOTED TO HAVE RESOLVED ONE (1) MONTH LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489815 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 289020 00880304475779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE NARRATIVE IN H11.