BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 3872485 · Received June 13, 2014

    Report

    Report Number
    0001825034-2014-05466
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    August 28, 2017
    Report Date
    October 9, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 14 STATES "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN SIDE ON (B)(6) 2005. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN AND DIFFICULTY WALKING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350327 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 958630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R