BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE HIP/SECTOR II CUP, 60MM

    MDR report key: 2003548 · Received February 19, 2011

    Report

    Report Number
    MW5019537
    Event Type
    Injury
    Date Received
    February 19, 2011
    Date of Event
    October 19, 2010
    Report Date
    February 19, 2011
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAD HIP REPLACEMENT USING PINNACLE SYSTEM WITH SECTOR II CUP AND ALTRX LINER ON (B)(6) 2011. HAS HAD INCREDIBLE PAIN AFTER SURGERY. HE HAS BEEN UNABLE TO SIT DOWN SINCE BEFORE (B)(6) WITHOUT TERRIBLE PAIN. HE'S HAD SWELLING IN THE ENTIRE LEG, HAD EVERY X-RAY, BLOOD TEST, AND SCAN IMAGINABLE AND WE'VE BEEN TOLD "EVERYTHING LOOKS GOOD". WE'VE SPEND (B)(6) ON TEST AND TREATMENTS, HAVE BEEN IN THE EMERGENCY ROOM 3 TIMES WITH HIM VOMITING FROM THE PAIN, AND HE IS NOW ON VERY STRONG NARCOTICS, LYRICA, AND HAS DONE SEVERAL ROUNDS OF STEROIDS AS WELL AS 3 SPINAL INJECTIONS. THE SURGEON HAS FINALLY DECIDED HE'D BETTER OPEN THIS JOINT AND SEE WHAT'S GOING ON. WE'VE HAD 4 MONTHS OF MISERY AND INCREDIBLE EXPENSE. NOT TO MENTION THE LOST WORK TIME. SOMETHING HAS TO BE WRONG WITH THAT JOINT. WE ARE STILL WAITING FOR A SURGERY DATE BUT ARE BEING TOLD WE WILL HAVE TO WAIT UNTIL PROBABLY (B)(6) BEFORE HE CAN BE FIT INTO THE SURGERY SCHEDULE. WE ARE VERY FRUSTRATED. I HOPE THIS INFO HELPS FIGURE OUT IF THERE IS A PROBLEM WITH THE PINNACLE SYSTEM. DIAGNOSIS OR REASON FOR USE: RIGHT HIP DEGENERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE HIP/SECTOR II CUP, 60MM DEPUY HIP, PINNACLE SYSTEM LPH
    2 DEPUY HIP REPLACEMENT S-ROM STEM 18X13 35 STD + 12 DEPUY HIP, PINNACLE SYSTEM LPH
    3 SLEEVE SZ 18F XXL DEPUY HIP, PINNACLE SYSTEM LPH
    4 ALTRX LINER SZ 40X60 +4 METAL HEAD SZ 40 -3 DEPUY HIP, PINNACLE SYSTEM KWA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention