BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVERSE ENHANCED GLENOSPHERE CENTRIC 36 MM DIAMETER +3 MM LATERAL OFFSET

    MDR report key: 21300106 · Received February 3, 2025

    Report

    Report Number
    0001822565-2025-00233
    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
    00889024489493
    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 H6: COMPONENT CODES: MECHANICAL (G04) - HEAD. 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#: 00436202000, BASE PLATE UNCEMENTED 20 MM POST LENGTH; LOT#: 65737055, 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
    57217 TM REVERSE ENHANCED GLENOSPHERE CENTRIC 36 MM DIAMETER +3 MM LATERAL OFFSET SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 64596107 00889024489493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R