BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BIOMET M2A HEAD

    MDR report key: 18565494 · Received January 23, 2024

    Report

    Report Number
    0001825034-2024-00148
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    May 16, 2022
    Report Date
    May 15, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, BUT NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: REVISION DUE TO METALLOSIS, THE ENTIRE BIOMET M2A METAL-ON-METAL PROSTHESIS AND ARTICULATING CONSTRUCT WAS REMOVED, EXCEPT FOR THE FEMORAL COMPONENT, AND REPLACED IT WITH AN ALTERNATIVE NON-METAL ON-METAL CONSTRUCT. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE M2A 38 HIP REPLACEMENT AND PLAINTIFF SUFFERED INJURIES, INCLUDING BUT NOT LIMITED TO ECONOMIC INJURY, PAIN AND SUFFERING, TISSUE DESTRUCTION, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, AND LIMITATION OF DAILY ACTIVITIES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVENT CONFIRMED VIA MEDICAL RECORDS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 15-105054 M2A 1 PC SHELL 38MMX54MM 175500 X11-180310 BI-METRIC/X POR NC LAT 10X130 791710. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2024 - 00147. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED EIGHTEEN (18) YEARS POST IMPLANTATION DUE TO PAIN AND METALLOSIS. DURING THE REVISION, THE INITIAL STEM WAS LEFT INTACT, AND ALL OTHER COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826188 UNK BIOMET M2A HEAD PROTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H SEE H10 NARRATIVE