BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP NECK

    MDR report key: 2922536 · Received January 15, 2013

    Report

    Report Number
    9616680-2013-90122
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    July 1, 2009
    Report Date
    December 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    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 PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS ADVISED TO REGISTER WITH STRYKER. HE IS EXPERIENCING PAIN AND IS UNABLE TO SLEEP ON HIS SIDE. PT REPORTS THAT HE HAS HAD AN MRI AND BLOOD TEST PERFORMED AND HE IS SCHEDULED TO HAVE HIS HIP ASPIRATED ON (B)(6) 2013. PT IS ALSO REPORTING THAT HIS COBALT LEVEL IS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22606 UNKNOWN LEFT HIP NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other