BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 23865504 · Received December 22, 2025

    Report

    Report Number
    0001825034-2025-04144
    Event Type
    Injury
    Date Received
    December 22, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    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 RECORDS 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 REVIEWED: COBALT: 11; HIGH. CHROME 20; HIGH. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: M2A-MAGNUM PF CUP 56ODX50ID. ITEM: US157856. LOT: 091660. TAPERLOC MICROP LAT FMRL 9.0MM. ITEM: 15-103203. LOT: 344230. M2A-MAGNUM 42-50MM TPR INSRT-6. ITEM: 139252. LOT: 377040. G2: FOREIGN ¿ CANADA. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. THE CUSTOMER INDICATED THAT THE PRODUCT LOCATION IS UNKNOWN; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HIGH METAL ION LEVELS. NO REVISION HAS BEEN REPORTED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605355 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 231470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11.