BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM 44MM

    MDR report key: 21763919 · Received April 3, 2025

    Report

    Report Number
    0001825034-2025-00981
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    June 26, 2023
    Report Date
    July 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: US157850 M2A-MAGNUM PF CUP 50ODX44ID (B)(6) 192511 ECHO POR FEM RED LAT NC 11X135 ( B)(6) 139256 M2A-MAGNUM 42-50 TPR INSRT STD 0/0MMT1 (B)(6). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D4, G3, G6, 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: PATIENT HAD A INITIAL THA. SUBSEQUENTLY PATIENT DEVELOPED PROGRESSIVE HIP PAIN AND WORK UP REVEALED METALLOSIS WITH AN ALVAL LESION. PATIENT HAS HIGH CHROMIUM AND COBALT LEVELS. PATIENT HAD A REVISION. DURING THE REVISION, CYSTIC LESION FLUID COLLECTION OF METALLOSIS DEBRIS WAS FOUND. THERE WERE MULTIPLE AREAS OF CRUMBLY TISSUE CONSISTENT WITH METALLOSIS REACTION. THE FEMORAL HEAD COMPONENT WAS REMOVED, THE TRUNNION WAS NORMAL IN APPEARANCE, TRUNNIONOSIS TYPE REACTION. THE ACETABULAR COMPONENT WAS REMOVED. TWO AREAS OF METALLOSIS IDENTIFIED BEHIND THE ACETABULAR COMPONENT WHICH WERE DEBRIDED. THE CUP, TAPER AND HEAD WERE EXPLANTED, REPLACED WITH NEW TAPER, HEAD, CUP, SCREWS AND LINER. THE STEM WAS RETAINED. NO OTHER COMPLICATIONS NOTED, HIP WAS STABLE THROUGHOUT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE MEDICAL RECORDS, THE COMPLAINT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PROGRESSIVE HIP PAIN AND THE WORK-UP REVEALED ELEVATED METAL ION LEVELS, INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH METALLOSIS 13 YEARS POSTOP. THE PATIENT UNDERWENT REVISION OF THE HEAD AND ACETABULAR COMPONENT WITHOUT ANY KNOWN COMPLICATIONS. FURTHER DETAILS HAVE NOT BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731335 M2A-MAGNUM MOD HD SZ 44MM 44MM PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 937480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE