BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER MEDIUM AUGMENTED BASEPLATE W/ MINI TAPER ADAPTER

    MDR report key: 20050654 · Received August 23, 2024

    Report

    Report Number
    0001825034-2024-02073
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    April 23, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304993242
    PMA / PMN Number
    K172502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): ¿ 113633 (65341166) ¿ 115396 (989040) ¿ 180550 (335350) ¿ 180550 (335420) ¿ 180552 (668420) ¿ 180553 (919240) ¿ 405800 (863030) ¿ 405889 (656140) ¿ 110030776 (65433896) ¿ 110031405 (65025926) ¿ 110031427 (65480933) ¿ 110031869 (65381527) ¿ 110040202 (65106097) ¿ 110040300 (65541193) ¿ 20800000010 (64972326) ¿ 20809000401 (65636501) G2: FOREIGN - THE EVENT OCCURRED IN AUSTRALIA THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6 THE REPORTED EVENT IS CONFIRMED VIA MMI. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: OVERALL FIT OF THE IMPLANT IS APPROPRIATE. DISASSEMBLY OF THE GLENOSPHERE WITH SUPERIOR POSITION BUT NO GLENOHUMERAL DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND 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

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE APPROXIMATELY EIGHTEEN (18) MONTHS POST-IMPLANTATION DUE TO COMPONENT DISASSOCIATION. 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
    1364403 COMPREHENSIVE REVERSE SHOULDER MEDIUM AUGMENTED BASEPLATE W/ MINI TAPER ADAPTER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65124560 00880304993242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H H11.