BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 58/52 R

    MDR report key: 1931056 · Received November 26, 2010

    Report

    Report Number
    1822565-2010-01199
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    November 9, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 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 (B)(6) 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)(6) CONSIDERS THIS CASE CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(6) .

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO HIP PAIN. RESURFACING SURGERY WAS IN (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER, INC. 2432819

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization