BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FEMORAL LAT 13.5X147

    MDR report key: 3397614 · Received October 9, 2013

    Report

    Report Number
    0001825034-2013-04546
    Event Type
    Injury
    Date Received
    October 9, 2013
    Report Date
    September 13, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ THIS REPORT IS NUMBER 7 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01938-1/01939-1 AND 02263-1/02265-1 AND 1825034-2013-04545/04546).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. PREVIOUS PATIENT ALLEGATIONS ALSO INCLUDED ELEVATED CHROMIUM LEVELS. NO REVISION HAS BEEN ALLEGED. 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
    512194 TAPERLOC POR FEMORAL LAT 13.5X147 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 037540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R