BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 13.5X147

    MDR report key: 4222994 · Received November 4, 2014

    Report

    Report Number
    0001825034-2014-08486
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    July 19, 2012
    Report Date
    October 27, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    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 4 STATES, ¿LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION, AND OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY.¿ NUMBER 5 STATES, ¿PERIARTICULAR CALCIFICATION OR OSSIFICATION, WITH OR WITHOUT IMPEDIMENT OF JOINT MOBILITY.¿ 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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06794, 06792, 07385 AND 08486).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2012 AND A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED DURING THE LEFT HIP REVISION PROCEDURE. ADDITIONAL INFORMATION REPORTED INDICATES A LEFT REVISION SURGERY OCCURRED ON (B)(6) 2014 ALLEGEDLY DUE TO PAIN. REVIEW OF INVOICE HISTORY CONFIRMED SURGERY DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORDS REVEALED THE LEFT HIP REVISION ON (B)(6) 2012 WAS DUE TO PAIN. THE PATIENT¿S OPERATIVE REPORT NOTED INFLAMMATION, FLUID, AND YELLOWISH RUBBERY TISSUE. ADDITIONAL INFORMATION IN PATIENT¿S MEDICAL RECORDS REVEALED THE RIGHT HIP REVISION ON (B)(6) 2012 WAS DUE TO PAIN AND NON-DISPLACED PERIPROSTHETIC FRACTURE. THE PATIENT¿S OPERATIVE REPORT NOTED HETEROTOPIC CALCIFICATION, SUBSIDED STEM, SCAR TISSUE, AND FRACTURE IN THE FEMUR. THE STEM AND HEAD WERE REMOVED AND REPLACED. FURTHER INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORDS NOTED THAT ON (B)(6) 2012 PATIENT¿S JOINT FLUID WAS TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708260 TAPERLOC POR FMRL LAT 13.5X147 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 969410

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R