BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 L

    MDR report key: 3851139 · Received May 23, 2014

    Report

    Report Number
    9613350-2014-03545
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 17, 2014
    Report Date
    November 24, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED ABOVE. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE RIGHT SIDE ON (B)(6) 2007. THE PT WAS REVISED ON JUNE (B)(6) 2014 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309041 DUROM ACETABULAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2343840

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R