BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 56MM

    MDR report key: 2141283 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-11041
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE AFTER THE IMPLANTATION OF THE PINNACLE HIPS, ON OR ABOUT (B)(6) 2006, PT BEGAN TO SUFFER FROM SEVERE PAIN IN HIS LEFT HIP AND SYMPTOMS OF A FAILED IMPLANT. IT IS FURTHER ALLEGED PT SUSTAINED AND CONTINUES TO SUFFER DAMAGES, INCLUDING, BUT NOT LIMITED TO, PAST, PRESENT, AND FUTURE PAIN AND SUFFERING, SEVERE AND POSSIBLY PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, ECONOMIC DAMAGES (INCLUDING MEDICAL AND HOSPITAL EXPENSES) MONITORING, REHABILITATIVE AND PHARMACEUTICAL COSTS, AND LOST WAGES AND LOSS OF FUTURE EARNINGS CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 56MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA ZR1HD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention