BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD -3MM NK

    MDR report key: 3811771 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04014
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04011 / 04014).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008, AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL REPORTED PATIENT'S ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, AND TISSUE AND BONE DESTRUCTION. THERE HAS BEEN NO REPORTED REVISION PROCEDURES TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289308 M2A 38MM MOD HEAD -3MM NK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 312580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R