BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 3851986 · Received June 5, 2014

    Report

    Report Number
    0001825034-2014-05267
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    August 26, 2014
    Report Date
    May 28, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05267 & 02515)

    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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, AND LACK OF MOBILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT UNDERWENT A BILATERAL HIP REVISION ON (B)(6) 2014. OPERATIVE REPORT FURTHER NOTED THE REASON FOR THE REVISION WAS HIGH CHROMIUM LEVELS. DURING THE REVISION, GRAYISH TYPE FLUID WAS FOUND IN THE LEFT HIP. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ON THE RIGHT HIP, THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AS WELL.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, AND LACK OF MOBILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT UNDERWENT A BILATERAL HIP REVISION ON (B)(6) 2014. OPERATIVE REPORT FURTHER NOTED THE REASON FOR THE REVISION WAS HIGH CHROMIUM LEVELS. DURING THE REVISION, GRAYISH TYPE FLUID WAS FOUND IN THE LEFT HIP. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ON THE RIGHT HIP, THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AS WELL.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, AND LACK OF MOBILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO 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
    329207 M2A 38MM MOD HD STD NK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 628970

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention