BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 21179809 · Received January 17, 2025

    Report

    Report Number
    0001825034-2025-00168
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 2, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): UNKNOWN GLENOID (UNKNOWN); 0001825034-2024-03034. UNKNOWN HUMERAL HEAD (UNKNOWN). ASSOCIATED PRODUCT INFORMATION: 115316 (903900), 115397 (66590559), 180552 (099800), 180552 (66843787), 180552 (66992928), 180558 (66190017), 405800 (66845066), 405883 (66983462), 110031418 (66783842), 110032410 (66817582), 20-8090-009-02 (67070103), SAHS1113 (66775292), SAHTNEM6 (67006924), SBHTST00 (65562537). H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - STEM. THE REPORTED EVENT IS UNCONFIRMED. 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. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND THAT 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 THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465246 UNKNOWN STEM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R