BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 48/42 H

    MDR report key: 2171109 · Received July 8, 2011

    Report

    Report Number
    9613350-2011-00456
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    February 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM (B)(6) WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE OPERATION REPORT HAS BEEN PROVIDED. IT CONFIRMS ASEPTIC LOOSENING OF THE ACETABULAR CUP. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(4) 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. AFTER THE SURGERY, THE PATIENT EXPERIENCED PAIN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2011. NO BONE INGROWTH ON THE CUP WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 48/42 H DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2359665

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O