BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FEMORAL 11X142 STEM

    MDR report key: 3648197 · Received February 26, 2014

    Report

    Report Number
    0001825034-2014-01227
    Event Type
    Injury
    Date Received
    February 26, 2014
    Report Date
    February 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 2 STATES. "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." 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.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-01217 / 01219, 01220 AND 1227).

    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. THIS REPORT IS NUMBER 4 OF 6 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-01217 / 01219, 01220 & 1227 & 2015-00753).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, DAMAGE TO SURROUNDING BONE AND TISSUE, ELEVATED METAL ION LEVELS. PATIENT'S LEGAL COUNSEL FURTHER ALLEGES AN UPCOMING RIGHT HIP REVISION PROCEDURE HAS BEEN INDICATED. NO RIGHT HIP REVISION PROCEDURE HAS BEEN REPORTED TO DATE. A REVIEW OF INVOICE HISTORY CONFIRMS THE RIGHT TOTAL HIP ARTHROPLASTY PROCEDURE AND THE LEFT HIP REVISION PROCEDURE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM WHAT WAS IMPLANTED IN THE PATIENT DURING THE INITIAL LEFT HIP PROCEDURE. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, DAMAGE TO SURROUNDING BONE AND TISSUE, ELEVATED METAL ION LEVELS. PATIENT'S LEGAL COUNSEL FURTHER ALLEGES AN UPCOMING RIGHT HIP REVISION PROCEDURE HAS BEEN INDICATED. NO RIGHT HIP REVISION PROCEDURE HAS BEEN REPORTED TO DATE. A REVIEW OF INVOICE HISTORY CONFIRMS THE RIGHT TOTAL HIP ARTHROPLASTY PROCEDURE AND THE LEFT HIP REVISION PROCEDURE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM WHAT WAS IMPLANTED IN THE PATIENT DURING THE INITIAL LEFT HIP PROCEDURE. 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 LEFT HIP OPERATIVE REPORTS NOTED PATIENT UNDERWENT AN INITIAL ARTHROPLASTY ON (B)(6) 2009 AND REVISION ON (B)(6) 2011 DUE TO PAIN AND ELEVATED METAL ION LEVELS. THE REVISION OPERATIVE REPORT NOTED THE PRESENCE OF METAL DEBRIS, CLOUDY GRAYISH FLUID, METALLOSIS, AND A LOOSE CUP. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119300 TAPERLOC POR LAT FEMORAL 11X142 STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 817260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention