BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 58/52 R

    MDR report key: 2123127 · Received June 6, 2011

    Report

    Report Number
    9613350-2011-00349
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC. , WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, OR X-RAYS. THE OP REPORT HAS BEEN REVIEWED. IT DOES NOT STATE ANY PECULIARITY. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. 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 GMBH CONSIDERS THIS CASE CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. IT IS REPORTED POST OP, PT EXPERIENCED PAIN AND WAS REVISED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2357489

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O