BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HUMERAL BEARING

    MDR report key: 22175445 · Received June 10, 2025

    Report

    Report Number
    0001825034-2025-01657
    Event Type
    Injury
    Date Received
    June 10, 2025
    Report Date
    July 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) B3: PUBLICATION DATE: MAY 2025. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10: UNK STEM CAT#UNK LOT#UNK, UNK HUMERAL TRAY CAT#UNK LOT#UNK. UNK GLENOSPHERE CAT#UNK LOT#UNK, UNK BASEPLATE CAT#UNK LOT#UNK, UNK CENTRAL SCREW CAT#UNK LOT#UNK, UNK PERIPHERAL SCREW CAT#UNK LOT#UNK. 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. HAWAYEK, B., MARTIN, S., MCGUIRE, M., CAIOLA, M., HAIDER, M. N., FENG, L., & DUQUIN, T. R. (N.D.). TREATMENT OF B2 TYPE GLENOIDS WITH ANATOMIC VERSUS REVERSE TOTAL SHOULDER ARTHROPLASTY: A RETROSPECTIVE REVIEW. JSES REVIEWS REPORTS AND TECHNIQUES. (2025) PGS 131-139. HTTPS://DOI.ORG/10.1016/J.XRRT.2025.01.001.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11 D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. THE REPORTED EVENT IS UNCONFIRMED. 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

    IN A JOURNAL STUDYING THE RESULTS OF TSAS AND RTSAS IN GLENOHUMERAL ARTHRITIC PATIENTS: IT WAS REPORTED THAT 1 PATIENT UNDERWENT A SINGLE STAGE REVISION WITH I&D ON AN UNKNOWN DATE DUE TO INFECTION. ALL COMPONENTS WERE EXCHANGED WITHOUT FURTHER COMPLICATIONS REPORTED. 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
    1265245 UNK HUMERAL BEARING PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.