BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE +3 MM LATERAL OFFSET 40 MM DIAMETER

    MDR report key: 16779757 · Received April 20, 2023

    Report

    Report Number
    0001822565-2023-01089
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 9, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231261
    PMA / PMN Number
    K181611
    Removal / Correction Number
    NI
    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

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS: 0001822565-2023-01088, ITEM#00434906606; LOT#63676333. OTHER ASSOCIATED PRODUCTS: ITEM#010000589; LOT#881160.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. B1: BOTH AE AND MALFUNCTION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS NOT CONFIRMED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206066 GLENOSPHERE +3 MM LATERAL OFFSET 40 MM DIAMETER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65560519 00887868231261

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R SEE NARRATIVE IN H10