BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET

    MDR report key: 18650395 · Received February 6, 2024

    Report

    Report Number
    0001825034-2024-00279
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 2, 2024
    Report Date
    June 12, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K193038
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE THE ASSOCIATED REPORTS: 0001825034-2024-00280. D10: CONCOMITANT MEDICAL PRODUCTS, PART NUMBER (LOT NUMBER): .113952 (233230). ASSOCIATED PRODUCT INFORMATION: 113611 (272300). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WAS DISCARDED AND 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. CORRECTION TO D1. H6: PROPOSED ANNEX G CODE - MECHANICAL (G04) HEAD. THE REPORTED EVENT IS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 THAT THE PATIENT UNDERWENT AN ANATOMIC SHOULDER REVISION APPROXIMATELY SIX (6) YEARS AND (2) MONTHS AFTER INITIAL IMPLANTATION DUE TO DISLOCATION. NO OTHER INJURIES WERE REPORTED, AND MEDICAL RECORDS ARE UNAVAILABLE FOR REVIEW. THE REVISION SURGERY WAS SUCCESSFUL. 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
    541778 COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. NI 265150

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R H10.