BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 J

    MDR report key: 3812510 · Received May 5, 2014

    Report

    Report Number
    9613350-2014-03494
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    October 30, 2013
    Report Date
    November 7, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PK053536
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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 INFORMATION 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR 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 PATIENT WAS IMPLANTED A DUROM US ACETABULAR COMPONENT ON THE LEFT SIDE ON (B)(6), 2007. THE PATIENT WAS REVISED ON (B)(6), 2013 DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267918 DUROM ACETABULAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2357525

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization| R