BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 50/44 J

    MDR report key: 4132721 · Received September 29, 2014

    Report

    Report Number
    9613350-2014-03922
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    January 22, 2009
    Report Date
    September 24, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 AS REFERENCE ABOVE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES 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 50/44 J ON THE LEFT SIDE ON (B)(6) 2008. THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605440 DUROM US ACETABULAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2432815

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R