BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -3MM NK

    MDR report key: 3953269 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06361
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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 ASSOCIATED 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND 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 FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012. THERE HAS BEEN NO REPORTED LEFT HIP 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 OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012 DUE TO TISSUE REACTION SECONDARY TO METAL ON METAL ARTICULATION. OPERATIVE REPORT FURTHER NOTED SEROUS FLUID AND EROSION OF THE GREATER TROCHANTER.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012. THERE HAS BEEN NO REPORTED LEFT HIP 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
    432014 28MM DIA COCR MOD HD -3MM NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 201460

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention