BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP REJUVENATE STEM

    MDR report key: 2926257 · Received January 16, 2013

    Report

    Report Number
    2249697-2013-90151
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    November 9, 2011
    Report Date
    December 27, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT WAS NOTIFIED BY HIS SURGEON ABOUT THE RECALL WHEN HE WENT IN FOR A CHECK UP. PT STATES THAT HE HAD AN MRI AND IT IS CURRENTLY SHOWING SOME FLUID ON HIS HIP. PT STATES THAT HIS DOCTOR WANTS TO MONITOR THE HIP FOR NOW AND THE PT WILL RETURN FOR A FOLLOW UP CHECK UP IN THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23853 UNKNOWN RIGHT HIP REJUVENATE STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other