BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUROM US ACETABULAR COMPONENT 50/44 J

    MDR report key: 1966616 · Received January 13, 2011

    Report

    Report Number
    9613350-2011-00017
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 7, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 JULY 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 AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PER 3 YEAR PHYSICAL EXAM FORM, THE DUROM CUP APPEARED TO BE LOOSE. NO REVISION SURGERY SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2367582

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR