BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT

    MDR report key: 21898695 · Received April 24, 2025

    Report

    Report Number
    0001822565-2025-01142
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    April 14, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    UDI-DI
    00889024271296
    PMA / PMN Number
    K123862
    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# 00840009500; LOT# 66458918, ITEM# 00840009000; LOT# 66462812, ITEM# 110029938; LOT# 116420, ITEM# 211240; LOT# 66114653. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - STEM. 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 RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED SIGNS OF USE WITH A GOUGE ON THE COLLAR AT THE PROXIMAL END OF THE REAMER. THERE IS SOME GALLING ON THE SHAFT OF THE REAMER AND THEN MORE DAMAGE TO THE COLLAR AT THE DISTAL END OF THE REAMER. THE STEP FEATURE ON THE DISTAL END OF THE REAMER IS ALSO CRACKED. MEASURED THE REAMER AND ALL MEASUREMENTS TAKEN WERE CONFORMING. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT WAS 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
    1124517 ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT PROSTHESIS, ELBOW, CONSTRAINED JDC ZIMMER BIOMET, INC. NI 63171877 00889024271296

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Hospitalization| R SEE NARRATIVE IN H11