BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR MODULAR RADIAL HEAD

    MDR report key: 21584250 · Received March 12, 2025

    Report

    Report Number
    0001825034-2025-00654
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 5, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    UDI-DI
    00880304210387
    PMA / PMN Number
    K051385
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 11-210062; LOT# 66148578. E1: FULL ESTABLISHMENT NAME - (B)(6). G2: FOREIGN - EVENT OCCURRED IN POLAND. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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; D20; G1; G3; G6; H1; H2; H3; H6; H10. D10: ITEM# 11-210062; LOT# 66148576. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - HEAD. 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. 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 INITIAL ELBOW IMPLANTATION APPROXIMATELY ONE (1) YEAR AGO AFTER EXPERIENCING AN ISOLATED, COMMINUTED FRACTURE OF THE RADIAL HEAD TWO (2) DAYS PRIOR. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE RADIAL HEAD PROSTHESIS. 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
    1400520 EXPLOR MODULAR RADIAL HEAD PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI ZIMMER BIOMET, INC. NI 311110 00880304210387

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Required Intervention| H SEE NARRATIVE IN H11.