BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BASEPLATE

    MDR report key: 9924404 · Received April 3, 2020

    Report

    Report Number
    0001825034-2020-01328
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: UNK GLENOSPHERE, UNK POLY. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO PERFORM A COMPATIBILITY CHECK. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN GLENOSPHERE, UNKNOWN HUMERAL BEARING, UNKNOWN HUMERAL TRAY, UNKNOWN HUMERAL STEM, UNKNOWN TAPER ADAPTOR. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01327. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS REMAINS IMPLANTED THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED PATIENT UNDERWENT INITIAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY PATIENT WAS REVISED THREE (3) MONTHS POST IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM BASE PLATE. GLENOSPHERE AND POLY WERE REVISED. ATTEMPTS WERE MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388986 UNK BASEPLATE PROSTHESIS, EXTREMITIES HSD ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R