BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP

    MDR report key: 3240831 · Received July 18, 2013

    Report

    Report Number
    9613350-2013-01749
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 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
    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 HAS NOT BEEN REVISED AND IS CURRENTLY BEING MONITORED. SINCE THE PT HAS NOT BEEN REVISED, THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP. IT WAS REPORTED BY PT'S COUNSEL THAT THE PT RECEIVED AN IMPLANT IN 2006. AT THE TIME OF THIS REPORT, THE PT IS CURRENTLY BEING MONITORED DUE TO UNK REASONS. FOR DATA ENTRY PURPOSES, THE FIRST DAY OF THE FIRST MONTH OF THE REPORTED YEAR WILL BE ENTERED AS THE IMPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335445 DUROM HIP DUROM HIP GENERIC KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other