BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVERSE ENHANCED BASE PLATE UNCEMENTED 20 MM POST LENGTH

    MDR report key: 21300089 · Received February 3, 2025

    Report

    Report Number
    0001822565-2025-00232
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 8, 2025
    Report Date
    June 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024489448
    PMA / PMN Number
    K172767
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. THE FOLLOWING SECTIONS WERE CORRECTED: A2; H4. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL COMPONENTS: ITEM#: 00436303600, GLENOSPHERE CENTRIC 36 MM DIAMETER +3 MM LATERAL OFFSET; LOT#: 64596107 ITEM#: 01.04223.033, INVERS/REVERS SCR SYST 4.5-33; LOT#: 3143468 ITEM#: 01.04223.036, INVERS/REVERS SCR SYST 4.5-36; LOT#: 3157880 ITEM#: 00434901013, 10MM ÿ 130MM LENGTH HUMERAL STEM; LOT#: 65901172 ITEM#: 00434903603; 36MM ÿ +3MM OFFSET POLY LINER; LOT#: 65585357 G3: FOREIGN: AUSTRALIA H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WILL NOT BE RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE DISASSOCIATION OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47864 TM REVERSE ENHANCED BASE PLATE UNCEMENTED 20 MM POST LENGTH SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 65737055 00889024489448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE