BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 11011079 · Received December 15, 2020

    Report

    Report Number
    0001825034-2020-04340
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    December 3, 2020
    Report Date
    March 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04341-1, 0001825034-202O-04342-1. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED ZONES OF LUCENCY SURROUNDING THE GLENOID COMPONENT, CONCERNING FOR LOOSENING AND/OR INFECTION. ASSESSMENT IS SOMEWHAT LIMITED SECONDARY TO POOR IMAGE QUALITY. A DEFINITIVE ROOT CAUSE COULD NOT 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). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04341, 0001825034-2020-04342.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT BIOMET COMPREHENSIVE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED TO A COMPETITOR SHOULDER DUE TO PAIN, POSSIBLE INFECTION, AND 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
    1479453 UNKNOWN HUMERAL HEAD PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK GLENOID CAT#NI LOT#NI| UNK HUMERAL STEM CAT#NI LOT#NI| UNK GLENOID CAT#NI LOT#NI| UNK HUMERAL STEM CAT#NI LOT#NI