BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 52/46 L

    MDR report key: 4284112 · Received November 21, 2014

    Report

    Report Number
    9613350-2014-04129
    Event Type
    Other
    Date Received
    November 21, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    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 IS CURRENTLY BEING MONITORED AND HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFIRMING. THE CAUSE FOR THIS SPECIFIC 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 CAUSE MIGHT BE/IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MED DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PRODUCT LIABILITY CLAIM WAS RAISED. IT IS REPORTED THAT THE PT WAS IMPLANTED A DUROM US ACETABULAR COMPONENT 52/46 L ON THE RIGHT SIDE ON (B)(6) 2007. CURRENTLY, THE PT IS BEING MONITORED DUE TO UNK REASONS. THIS IS A SPLIT CASE WITH ZIMMER INC. FROM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757164 DUROM US ACETABULAR COMPONENT 52/46 L DUROM US ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2403160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other