BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP NECK

    MDR report key: 2910796 · Received January 8, 2013

    Report

    Report Number
    9616680-2013-90050
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 10, 2011
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. DEVICE INFO HAS NOT BEEN PROVIDED AT THE TIME. INFO RECEIVED FROM THE PT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCE IN THE REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PT HAS BEEN EXPERIENCING PAIN SINCE SURGERY. PT HAD PROCEDURE FOR CALCIFICATION IN (B)(6) 2012. PT ALSO HAS HAD X-RAY AND MRI DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10140 UNKNOWN RIGHT HIP NECK IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention