BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP STEM

    MDR report key: 2926231 · Received January 16, 2013

    Report

    Report Number
    2249697-2013-90158
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    February 2, 2010
    Report Date
    December 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
    LA, 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. 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 PATIENT HAD BILATERAL HIP IMPLANTS. PATIENT HAS BEEN COMPLAINING OF PAIN IN BOTH HIPS AND ALSO THAT HIS COBALT LEVELS ARE ELEVATED. PATIENT IS SCHEDULED TO HAVE AN MRI THE WEEK OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24862 UNKNOWN LEFT HIP STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other