BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUROM US ACETABAR COMPONENT 52/46 L

    MDR report key: 1739975 · Received June 23, 2010

    Report

    Report Number
    9613350-2010-00299
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    August 23, 2007
    Report Date
    May 27, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2007-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 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 DEVICE(S) BE RETURNED FOR EVAL 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

    PT REPORTS THAT SHE UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6)2007. POST-OP PT HAS BEEN EXPERIENCING PAIN DUE TO LOOSENING, HER DR HAS RECOMMENDED A REVISION, WHICH IS NOT YET SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other