BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN REVITAN HIP

    MDR report key: 4272021 · Received November 6, 2014

    Report

    Report Number
    9613350-2014-04089
    Event Type
    Other
    Date Received
    November 6, 2014
    Date of Event
    April 25, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION SINCE IT IS STILL IMPLANTED. NO X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN UNKNOWN REVITAN HIP ON THE LEFT SIDE ON (B)(6) 2013. THE PATIENT WAS MONITORED AND IT WAS REPORTED THAT HE CLAIMED FEELING PAIN IN THE LEFT GROIN ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713119 UNKNOWN REVITAN HIP UNKNOWN REVITAN HIP JDI ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other