BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE NECK

    MDR report key: 2871908 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01335
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    October 1, 2010
    Report Date
    November 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE REJUVENATE. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED, THE PT LEARNED OF THE RECALL THROUGH A TELEVISION ADVERTISEMENT AND CONFIRMED THE RECALL STATUS OF HIS IMPLANT THROUGH HIS SURGEON. THE PT REPORTS HAVING PAIN THAT EXTENDS FROM THE TOP OF HIS HIP DOWN TO HIS KNEE, SWELLING IN THE HIP, AND NUMBNESS ON THE BOTTOM OF HIS RIGHT FOOT FOR APPROX ONE YR. THE PT FREQUENTLY HAS A POPPING SENSATION IN THE HIP. HE HAS A PROMINENT LIMP AND SOMETIMES NEED A CANE. THE PT SAW HIS SURGEON ON (B)(6) 2012. AN MRI AND BLOOD TEST WERE PRESCRIBED. THE PT STATES, HE IS UNABLE TO PAY FOR THE TESTING BECAUSE HE DOES NOT HAVE INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT REJUVENATE NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R