BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 24344814 · Received February 16, 2026

    Report

    Report Number
    0001825034-2026-00355
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    August 19, 2024
    Report Date
    April 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: CAT # 192511 LOT # 558790 ECHO POR FEM RED LAT NC 11X135. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE INNER SPHERICAL SURFACE IS SCRATCHED AND GOUGED. OUTER SPHERICAL SURFACE HAS EMBEDDED BIO DEBRIS. NO OTHER DAMAGE WAS NOTED. MODULAR HEAD WAS RETURNED WITH TAPER ADAPTER MATED. DEVICES SHOW WEAR FROM USE. NICKS, SCRATCHES, AND GOUGES ARE NOTED TO THE SPHERICAL SURFACE, BOTTOM, AND TAPER WALL OF BOTH DEVICES. NO OTHER DAMAGE WAS NOTED. BIO DEBRIS IS PRESENT ON THE DEVICE. 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 RIGHT INITIAL THA. PATIENT LATER DEVELOPED HIP PAIN AND FOLLOW UP TESTS REVEALED ELEVATED METAL IONS WHERE CHROMIUM AND COBALT WERE HIGH. PATIENT HAD A HIP REVISION. INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH METALLOSIS. DEEP TO THE FASCIA A MODERATE SEROMA WAS ENCOUNTERED WITH BROWNISH FLUID, THE TISSUES WERE SLIGHTLY HEMOSIDERIN STAINED. THE FLUID WAS EVACUATED AND ABNORMAL TISSUE DEBRIDED SHARPLY. THE FEMORAL HEAD WAS REMOVED WITH A TAMP. THE TRUNNION WAS NORMAL IN APPEARANCE. THE ACETABULAR COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS AND A NEW CUP PLACED. NO OTHER COMPLICATIONS WERE NOTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED HIP PAIN AND THE WORK-UP REVEALED ELEVATED METAL ION LEVELS, INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH METALLOSIS. THE PATIENT UNDERWENT REVISION OF THE HEAD AND ACETABULAR COMPONENT WITHOUT ANY KNOWN COMPLICATIONS. FURTHER DETAILS HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406093 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 196690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R