BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD HYBRID GLENOID BASE 4MM

    MDR report key: 17210739 · Received June 27, 2023

    Report

    Report Number
    0001825034-2023-01430
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    May 31, 2023
    Report Date
    August 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00880304462489
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ABLE TO BE CONFIRMED BY REVIEW OF THE PROVIDED PHOTOGRAPHS. VISUAL EXAMINATION OF THE PICTURES IDENTIFIED THAT THE POLY APPEARS TO BE WORN AND COVERED WITH BIODEBRIS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: VERSA-DIAL/COMP TI STD TAPER, CAT #: 118001, LOT #: 264620; VERSA-DIAL 54X24X58 HUM HEAD, CAT #: 113065, LOT #: 394810; PT HYBRID GLEN POST REGENEREX, CAT #: PT-113950, LOT #: 918860; COMP PRIMARY STEM 16MM MINI, CAT #: 113636, LOT #: 733320. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. 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
    1453316 MD HYBRID GLENOID BASE 4MM SHOULDER, PROSTHESIS HSD ZIMMER BIOMET, INC. 113954 296400 00880304462489

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10