BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE SHOULDER HUMERAL HEAD

    MDR report key: 13951900 · Received March 30, 2022

    Report

    Report Number
    0001825034-2022-00561
    Event Type
    Injury
    Date Received
    March 30, 2022
    Report Date
    March 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. 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. SPERLING, JOHN W, MARIGI, ERICK M, LENARTOWICZ, KARINA A, JENNEWINE, BRENTON, THROCKMORTON, THOMAS W. (2022) CLINICAL AND RADIOGRAPHIC OUTCOMES OF HYBRID GLENOID FIXATION WITH A CENTRAL POROUS. TITANIUM POST: ANALYSIS OF 713 CONSECUTIVE SHOULDERS, JOURNAL OF SHOULDER AND ELBOW SURGERY. HTTPS:// DOI.ORG/10.1016/J.JSE.2021.12.033.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE FROM THE JOURNAL OF SHOULDER AND ELBOW SURGERY, WHICH STUDIED PATIENT OUTCOMES AFTER PRIMARY ELECTIVE HYBRID TOTAL SHOULDER ARTHROPLASTIES, THAT 5 PATIENTS UNDERWENT A REOPERATION OR REVISION PROCEDURE DUE TO A ROTATOR CUFF TEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699386 UNKNOWN COMPREHENSIVE SHOULDER HUMERAL HEAD SHOULDER PROSTHESIS PHX ZIMMER BIOMET, INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H