BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 58/52 R

    MDR report key: 2041310 · Received March 22, 2011

    Report

    Report Number
    9613350-2011-00168
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    September 7, 2010
    Report Date
    March 8, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 THE EXPLANTED DEVICES OR X-RAYS. THE SURGICAL REPORT OF THE REVISION CONFIRMS THAT THE CUP WAS LOOSE. WHERE LOT NUMBERS WERE REC'D FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. 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 BY PT'S COUNSEL THAT PT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. IT IS ALSO REPORTED THAT POST OP, PT EXPERIENCED PAIN AND LOOSENING AND WAS REVISED ON (B)(6) 2010.

    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 2433626

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O