BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER

    MDR report key: 16598893 · Received March 23, 2023

    Report

    Report Number
    0001822565-2023-00796
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    February 23, 2023
    Report Date
    June 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024269194
    PMA / PMN Number
    K130661
    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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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. 0001825034-2023-00625, ITEM#115313; LOT#J7407973. 0001822565-2023-00797, ITEM# UNKOWN STEM; LOT# UNKOWN. OTHER ASSOCIATED PRODUCTS : ITEM#00-4349-066-06; LOT#63676333, ITEM#110030777; LOT#65560519, ITEM#010000589; LOT#881160, ITEM#115313; LOT#J7407973, ITEM#118000; LOT#J7329702.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: STEM IDENTIFICATION FOUND: 18MM 130MM LENGTH HUMERAL STEM CAT#: 00434901813 LOT#: 64008964. VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED THERE IS DAMAGE THE SPHERICAL RADIUS, RIM FEATURE, AND BACKSIDE FEATURES. DUE TO DAMAGE, DIMENSIONAL ANALYSIS 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. 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 A PATIENT UNDERWENT SHOULDER REVISION DUE TO DISLOCATION. DURING THE PROCEDURE, IT WAS NOTED THE POLYETHYLENE HAD DISASSOCIATED FROM THE STEM. THE GLENOSPHERE AND POLYETHYLENE WERE REMOVED AND REPLACED. 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
    367222 36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65566647 00889024269194

    Patients

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