BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 23291169 · Received October 15, 2025

    Report

    Report Number
    0001825034-2025-03221
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 27, 2016
    Report Date
    February 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: PATIENT HAD A INITIAL LEFT THA. PATIENT IS REVISED DUE TO PAINFUL LEFT THA. DURING THE REVISION, SIGNIFICANT AMOUNT OF FLUID AND BURSAL DEHISCENCE NOTED, THE FLUID WAS SENT FOR CULTURE AND GRAM STAIN. STEM IS FOUND TO BE STABLE. CUP WAS EXPLANTED WITHOUT BONE LOSS. EVIDENCE OF METALLOSIS AT TRUNNION LEVEL AND BLACK COLLAR VISIBLE ON TRUNNION. HEAD AND TAPER ADAPTER WERE EXPLANTED AND NEW IMPLANTS PUT IN. NO OTHER COMPLICATIONS WERE NOTED. 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 FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# X180913, LOT# 180650 STEM. G2: FOREIGN: CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS LATER DUE TO PAIN. DURING THE REVISION, NOTED METALLOSIS AND BURSITIS. THE HEAD AND SHELL WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288826 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 328490

    Patients

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