BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 7395225 · Received April 4, 2018

    Report

    Report Number
    0001825034-2018-02356
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    April 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A 38MMX50MM CUP CAT: RD118850 LOT: 792180, TAPERLOC MICROP FMRL 11.0MM CAT: 14-103205 LOT: 419280. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEW STATES ABSENCE OF THE GREATER TROCHANTER AND MILD HETEROTOPIC OSSIFICATION. SMALL INCLINATION ANGLE OF THE ACETABULAR CUP WITH MORE HORIZONTAL ORIENTATION THAN EXPECTED. NO HARDWARE FRACTURE SEEN. POSSIBLE RADIOLUCENCY ALONG THE MEDIAL ACETABULUM AT THE CEMENT HARDWARE INTERFACES. 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 PATIENT HAD A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST PRIMARY SURGERY, DUE TO DISLOCATION AND METAL ON METAL REACTION. DURING THE REVISION, THE CUP WAS REPLACED AND TWO SCREWS WERE PUT IN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239263 M2A 38MM MOD HD +3MM NK HIP, PROSTHESIS LZO ZIMMER BIOMET, INC. 601580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R