BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR 40MM GLENOSPHERE +3MM COCR

    MDR report key: 17189682 · Received June 23, 2023

    Report

    Report Number
    0001822565-2023-01669
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 30, 2023
    Report Date
    November 2, 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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-01667, 0001822565-2023-01668. D10: ITEM# 110031406; LOT# 65255271, ITEM# 110031428; LOT# 64862430, ITEM# 113636; LOT# 64964393, ITEM# 010000589; LOT# 004910, ITEM# 180551; LOT# 162950, ITEM# 180553; LOT# 181350, ITEM# 115395; LOT# 346240, ITEM# 405800; LOT# 495010, ITEM# 406669; LOT# 554790, ITEM# 405889; LOT# 413380, ITEM# 180556; LOT# UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. THE GLENOSPHERE WAS NOT RETURNED, AND VISUAL EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A 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. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY THREE (3) WEEKS AGO DUE TO EXPERIENCING MULTIPLE POSSIBLE DISLOCATIONS. SUBSEQUENTLY, DURING THE REVISION IT WAS NOTED THAT THE HUMERAL BEARING COMPLETELY DISASSOCIATED FROM THE HUMERAL TRAY AND VISUAL INSPECTION OF THE BEARING NOTES DAMAGE OF THE BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1823744 CR 40MM GLENOSPHERE +3MM COCR SHOULDER, PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65054408 00887868231261

    Patients

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