BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL ALPHA INSERT NEUTRAL JJ/36

    MDR report key: 4142594 · Received September 30, 2014

    Report

    Report Number
    9613350-2014-03932
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    February 14, 2011
    Report Date
    September 8, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, 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 WAS IMPLANTED A DURASUL ALPHA INSERT NEUTRAL JJ/36 ON THE LEFT SIDE ON (B)(6) 2008. DUE TO RECURRENT SUBLUXATION OF LEFT HIP, THE PT WAS REVISED FOR THE SECOND TIME ON (B)(6) 2011 (FIRST REVISION SURGERY: (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608011 DURASUL ALPHA INSERT NEUTRAL JJ/36 DURASUL-INLAY ALPHA INSERT NEUTRAL JJ/36 LZO ZIMMER GMBH 2462958

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R