BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 36MM

    MDR report key: 15690140 · Received October 28, 2022

    Report

    Report Number
    0001825034-2022-02395
    Event Type
    Injury
    Date Received
    October 28, 2022
    Report Date
    December 14, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475779
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE PRODUCT CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: ITEM# 110031420; LOT# 64663507. ITEM#32-486265; LOT#439360. ITEM#32-486265 LOT#960570. ITEM#20-8090-003-02; LOT#65236417. ITEM#110040202; LOT#64909442. ITEM#110040300; LOT#65106148. ITEM#405889; LOT#698720. ITEM#405800; LOT#495020. ITEM#110031869; LOT#65118357. ITEM#110003484; LOT#664930. ITEM#010000589; LOT#930690. ITEM#115396; LOT#318140. ITEM#180551; LOT#072620. ITEM#180550; LOT#344530. ITEM#110031399; LOT#65142044. ITEM#912040; LOT#205700. ITEM#912030; LOT#P10452. ITEM#912030; LOT#P10177. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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: COMPONENT CODE - PROPOSED CODE: MECHANICAL (G04)- HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. IT WAS INDICATED THAT THE DISLOCATION OCCURRED WHILE THE PATIENT WAS CHANGING A TIRE. HOWEVER, WITH THE PROVIDED INFORMATION 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

    IT WAS REPORTED THAT THE PATIENT IS INDICATED TO NEED A REVISION PROCEDURE, APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO DISLOCATING THEIR SHOULDER WHILE CHANGING A TIRE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2912871 COMP RVSR SHLDR GLNSP +3 36MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 072910 00880304475779

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE NARRATIVE IN H10