BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS NEXEL DISTAL BODY

    MDR report key: 21898697 · Received April 24, 2025

    Report

    Report Number
    0001825034-2025-01192
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    April 14, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    UDI-DI
    00880304806030
    PMA / PMN Number
    K153398
    Removal / Correction Number
    NI
    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). D10: ITEM# 211240; LOT# 66114653, ITEM# 00840002411; LOT# 63171877, ITEM# 00840009500; LOT# 66458918, ITEM# 00840009000; LOT# 66462812. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE IMPLANT CONSTRUCT AFTER IT WAS EXPLANTED. BIO-DEBRIS IS PRESENT ON THE IMPLANTS. NO PART OR LOT INFORMATION IS PICTURED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TWO VIEWS OF THE RIGHT HUMERUS AND ELBOW DEMONSTRATE A RIGHT ELBOW ARTHROPLASTY WITH THREE PROXIMAL CERCLAGE WIRES. NO RADIOLUCENCY IS NOTED. ON THE LATERAL FILM, THERE IS AN OSSIFIC DENSITY AT THE LEVEL OF THE OLECRANON WHICH IS NOT SEEN ON AP FILM. NO DEFINITE LOOSENING IS SEEN. 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. THE REPORTED EVENT IS NOT CONFIRMED. 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 UNDERWENT AN ELBOW REVISION APPROXIMATELY SEVEN (7) MONTHS POST-IMPLANTATION DUE TO SQUEAKING OF ELBOW AND EXCESSIVE ROM. THE SURGEON ORIGINALLY PLANNED TO REVISE DISTAL BODY; HOWEVER, THE WHOLE IMPLANT WAS LOOSE AND WAS REMOVED AND REPLACED. 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
    1124519 COMPREHENSIVE SRS NEXEL DISTAL BODY PROSTHESIS, ELBOW, CONSTRAINED JDC ZIMMER BIOMET, INC. NI 116420 00880304806030

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Required Intervention| H SEE NARRATIVE IN H11.