BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 1842787 · Received September 10, 2010

    Report

    Report Number
    9613350-2010-00426
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 3, 2009
    Report Date
    August 14, 2009
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN THE (B)(6). THE RETRIEVAL HAS BEEN SENT TO THE (B)(6) FOR EVAL. ZIMMER (B)(4) DID NOT RECEIVE AND DO NOT EXPECT FURTHER INFO. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR PRODUCT FAILURE LEAD TO THE REPORTED ISSUE. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUE FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MDR WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDER THIS COMPLAINT FILE (B)(4) CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT A REVISION SURGERY DUE TO IMPLANT (DUROM CUP) LOOSENING. CASE WAS REPORTED TO THE (B)(6) VIA THE (B)(6). RETRIEVAL, BLOOD SAMPLES AND SOFT TISSUE SAMPLES HAVE BEEN SENT TO THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA 2192898

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization