BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ4 HI OFF

    MDR report key: 2943861 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-01420
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    August 16, 2012
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. SHE ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HER HIP WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE: (B)(4) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE THE STEM WAS GROSSLY LOOSE AND SUBSIDED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47870 SUMMIT POR TAPER SZ4 HI OFF TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS INC US EX4AR1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention