BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 3772155 · Received March 28, 2014

    Report

    Report Number
    9613350-2014-03409
    Event Type
    Other
    Date Received
    March 28, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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 EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION 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 / IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT RECEIVED A DUROM US ACETABULAR COMPONENT 54/48 N ON LEFT SIDE ON (B)(6) 2006 AND BEING MONITORED DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185332 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other