BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2821366 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-01969
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    April 1, 2010
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PAIN BEGAN APPROXIMATELY ONE MONTH AFTER THE IMPLANT. HE WAS GIVEN STEROID SHOTS TO RELIEVE THE PAIN. HE EVENTUALLY HAD A SECOND SURGERY TO RELEASE THE TENDONS TO PROVIDE RELIEF FROM THE PAIN. THE PATIENT STATES THAT THE PROCEDURE DID NOT RELIEVE HIS PAIN. HE RECENTLY HAD A DOCTOR'S APPOINTMENT ON (B)(6) 2012. THE DOCTOR SAID ALL HIS BLOOD LEVELS WERE ELEVATED. HIS MRI SHOWED ANOMALIES IN THE HIP AREA. HIS SURGEON STATES THAT HE WILL NEED A REVISION SURGERY AS SOON AS POSSIBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R