BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    MDR report key: 3240822 · Received July 18, 2013

    Report

    Report Number
    9613350-2013-01738
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, SINCE THE PT HAS NOT BEEN REVISED AND IS CURRENTLY BEING MONITORED. 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 FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. AN UPDATED REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFO IS RECEIVED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    THE PT WAS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF DUROM ACETABULAR CUP. IT WAS REPORTED BY THE PT'S COUNSEL THAT THE PT RECEIVED AN IMPLANT ON (B)(6) 2005. NO REVISION INFO IS MADE AVAILABLE. AT THE TIME OF THIS REPORT, THE PT IS CURRENTLY BEING MONITORED DUE TO LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335231 DUROM ACETABULAR COMPONENT 58/52 CODE R DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other