BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR LATERALIZED TAPERLOC FEMORAL POROUS COATED 12.5 X 145 MM STEM TYPE I TAP

    MDR report key: 2834181 · Received November 15, 2012

    Report

    Report Number
    0001825034-2012-02428
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    December 17, 2008
    Report Date
    November 6, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE. THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS AND INSTRUMENTS, PRIOR TO PERFORMING SURGERY. 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 EVENT (REFERENCE 1825034-2012-01371-1 / 01373-1 & 2428).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2008 ALLEGEDLY DUE TO METALLOSIS AND IMPINGEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED 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
    1 MODULAR LATERALIZED TAPERLOC FEMORAL POROUS COATED 12.5 X 145 MM STEM TYPE I TAP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 151700

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R