BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE BE

    MDR report key: 19116290 · Received April 16, 2024

    Report

    Report Number
    0001822565-2024-01106
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    October 4, 2022
    Report Date
    April 16, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231520
    PMA / PMN Number
    K181611
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-01105. D10: ITEM# 110030778; LOT# 64602060. ITEM# 115398; LOT# 773130. ITEM# 110027734; LOT# 851700. ITEM# 110031378; LOT# 851710. ITEM# 180554; LOT# 464910. ITEM# 180554; LOT# 760820. ITEM# 180556; LOT# 810400. ITEM# 180556; LOT# 750010R. ITEM# 113650; LOT# 65156183. ITEM# 180555; LOT# 369160. ITEM# 180556; LOT# 658960. ITEM# 180555; LOT# 962370. ITEM# 110031399; LOT# 65404532. 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. 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 BY THE PMI GROUP THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THE PROCEDURE, THE POLY WAS EXCHANGED AND THE GLENOSPHERE AND VRS COMPONENTS REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446908 COMPREHENSIVE REVERSE SHOULDER SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE BE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65007463 00887868231520

    Patients

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