BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 48/42 H

    MDR report key: 1890061 · Received October 26, 2010

    Report

    Report Number
    9613350-2010-00491
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER, INC., WHICH MARKETS THE DEVICE IN THE U.S. THE MEDICAL DEVICE WILL BE RETURNED TO MFR FOR INVESTIGATION. X-RAYS, OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED OR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE THE COMMON CLINICAL PRESENTATION AND THE ASSUMED DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 7/2008. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE RESULTS OF INVESTIGATION ARE DIFFERENT TO THE RESULTS FROM INVESTIGATIONS ALREADY PERFORMED, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER APPROX 2 YEARS AFTER IMPLANTATION, A REVISION SURGERY WAS OCCURRED ON (B)(6) 2010, DUE TO PAIN. IT IS REPORTED THAT THERE WAS NO BONE INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 48/42 H DUROMA ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA 2423574

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R