BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 12X165MM

    MDR report key: 4013704 · Received August 15, 2014

    Report

    Report Number
    0001825034-2014-07122
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    April 15, 2013
    Report Date
    July 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 OR 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, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03853, 07120, 07122 AND 07123).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013, DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DIFFICULTY WALKING, LOSS OF RANGE OF MOTION, DAMAGE TO BONE/TISSUE AND METALLOSIS. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE SURGERY DATES OR WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT RIGHT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN. THE PATIENT¿S OPERATIVE REPORT NOTED METAL STAINED TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490137 MLRY-HD POR FMRL 12X165MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 688590

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R