BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 52/46 L

    MDR report key: 2211350 · Received July 1, 2011

    Report

    Report Number
    9613350-2011-00434
    Event Type
    Other
    Date Received
    July 1, 2011
    Date of Event
    April 4, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER IN., WHICH MARKETS THE DEVICES IN THE UNITED STATES. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS OR OTHER RELEVANT SOURCE DOCUMENTS. 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 INFO 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 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

    IT IS REPORTED THAT THE PT UNDERWENT A LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2007. IT IS ALSO REPORTED THAT POST OP THE PT EXPERIENCED PAIN. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2011 DUE TO LOOSENING OF THE ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2336492

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O