BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELEX / M2A-MAGNUM

    MDR report key: 23895620 · Received December 26, 2025

    Report

    Report Number
    0001825034-2025-04175
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    July 15, 2025
    Report Date
    May 19, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K062997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6; H10. 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 PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LAB REPORT: ELEVATED METAL IONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS CONFIRMED. 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: CAT# 11-103201 LOT# 230140 TAPERLOC POR LAT FMRL 6.0X132 . G2: FOREIGN - EVENT OCCURRED IN CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWELVE YEARS POST RIGHT HIP IMPLANTATION, THE PATIENT EXPERIENCED HIGH METAL ION LEVELS. NO OTHER SYMPTOMS, TREATMENT, OR SURGICAL INTERVENTION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510308 SELEX / M2A-MAGNUM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 641410

    Patients

    Seq Age Sex Outcome Treatment
    1