BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6464552 · Received April 6, 2017

    Report

    Report Number
    0001825034-2017-02356
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    August 12, 2015
    Report Date
    October 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED DUE TO PRODUCT LOCATION UNKNOWN TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: 11-103208 NAME: TAPERLOC POR LAT FMRL 15X150 LOT: 801650. PART: 139266 NAME: M2A-MAGNUM 52-60 MM TPR INSRT-3 LOT: 811200. PART: US157858 NAME: M2A-MAGNUM PF CUP 58ODX52ID LOT: 203850. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS (REFERENCE 0001825034-2017-02350).

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. REVISION OPERATIVE FINDINGS SHOW SURGEON NOTED THE METAL TINGED FLUID WITH REACTIVE LYMPHOCYTES AND THE CAPSULE WAS FOUND TO BE CONSISTENT WITH AN ACTUE LOCAL TISSUE REACTION SECONDARY TO THE METALLOSIS, SCLEROTIC BONE EROSION, AND STRESS SHIELDING BEHIND THE CUP. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT A PATIENTS RIGHT HIP WAS REVISED APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO PAIN. THE HEAD AND CUP WERE REMOVED. SIGNS OF METALLOSIS WERE FOUND DURING THE REVISION. EVIDENCE OF HEAD EROSION FOUND AS WELL AS SIGNS OF ADVERSE LOCAL TISSUE REACTIONS AROUND SOME OF THE SCLEROTIC BONE IN THE GREATER TROCHANTER REGION. STRESS SHIELDING BEHIND THE CUP WAS ALSO FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246495 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 803020

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R