BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A-MAGNUM 42-50MM TAPER INSERT-6

    MDR report key: 6108155 · Received November 16, 2016

    Report

    Report Number
    0001825034-2016-04717
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    August 18, 2014
    Report Date
    September 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A MAGNUM CUP, CATALOG#: US157848, LOT#: 092790, BIOMET TAPERLOC STEM, CATALOG#: 103201, LOT#: 340660. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02138 AND 04717).

    Additional Manufacturer Narrative · 1

    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 DURING A HIP PROCEDURE THE FEMORAL HEAD WAS FOUND COLD WELDED TO THE STEM. A BURR WAS USED TO REMOVE THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756349 M2A-MAGNUM 42-50MM TAPER INSERT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 467960

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other