BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP

    MDR report key: 3150093 · Received June 3, 2013

    Report

    Report Number
    9613350-2013-01607
    Event Type
    Other
    Date Received
    June 3, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT IS CURRENTLY BEING MONITORED AND HAS NOT BEEN REVISED TO DATE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, AS THE PT HAS NOT BEEN REVISED. THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES. SHOULD ADD'L INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM HIP GENERIC ON THE RIGHT SIDE ON AN UNK DATE. A REVISION SURGERY IS PLANNED. CURRENTLY, THE PT IS BEING MONITORED DUE TO FLUID COLLECTING AROUND THE JOINT, ELEVATED ION LEVELS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242762 DUROM HIP DUROM HIP GENERIC KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other