BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 1912344 · Received November 2, 2010

    Report

    Report Number
    1818910-2010-08247
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 23, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    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

    VOLUNTARY REPORT STATES: DEPUY PINNACLE HIP REPLACEMENT WAS PERFORMED ON 2007. THE PART NEVER PERFORMED CORRECTLY. I HAD CONTINUOUS PAIN AND DISCOMFORT. I WAS TOLD BY THE DOCTOR THAT PERFORMED THE SURGERY, THAT THE PART WAS IN THE CORRECT POSITION. I HAVE HAD NOTHING BUT EXTREME PAIN AND LIMITED MOBILITY SINCE THE FIRST SURGERY. IN 2009, A 7CM X 4CM CYST WAS DISCOVERED AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO DRAIN IT. IT IS BURIED BACK IN BEHIND THE BLOOD VESSELS IN MY GROIN AREA. COME TO FIND OUT THE GROWTH IS AN PSEUDO-TUMOR CAUSED BY THE METAL ON METAL. I HAVE HAD A 3 DIMENSIONAL BODY SCAN AND NUMEROUS OTHER TESTS ORDERED BY THE ORIGINAL SURGEON. HE RELUCTANTLY SAID THAT HE WOULD NEED TO DO EXPLORATORY SURGERY AND POSSIBLY HE MIGHT HEED TO REPLACE THE METAL BALL WITH CERAMIC PARTS. ON 2010, I HAD A DIFFERENT SURGEON REPLACE MY HIP. HE FOUND THAT THE PINNACLE PART WAS FLOATING FREE IN THERE. IT NEVER ADHERED ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX20MM 87NDJ 87LPH NDJ DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC NA BP8BL4000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention NA.