BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 8X28MM IMPL STEM W/SCR

    MDR report key: 22689111 · Received August 1, 2025

    Report

    Report Number
    0001825034-2025-02344
    Event Type
    Injury
    Date Received
    August 1, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    UDI-DI
    00880304210462
    PMA / PMN Number
    K040611
    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: MEDICAL PRODUCTS: ITEM#: 11-210041, EXPLOR 10X24 MM IMPLANT HEAD; LOT#: 967370. ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN . G2: FOREIGN: POLAND. H3: 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. H6: COMPONENT CODES: MECHANICAL (G04) - STEM. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6 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. SOFT TISSUE METALLOSIS: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CAPITULUM HUMERI SURFACE DESTRUCTION: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS IT IS UNKNOWN HOW THE CAPITULUM HUMERI SURFACE WAS DAMAGED. IT COULD HAVE BEEN DUE TO BONE LOSS, SECONDARY TO METALLOSIS, OR CAUSED BY ANOTHER UNREPORTED ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.

    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
    1136279 EXPLOR 8X28MM IMPL STEM W/SCR PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES KWI ZIMMER BIOMET, INC. 680450 00880304210462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.