BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11

    MDR report key: 2915528 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90086
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION INCLUDING X-RAYS AND MEDICAL RECORDS WAS NOT MADE AVAILABLE EITHER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PATIENT EXPERIENCING HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14949 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJRDPN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention