BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT

    MDR report key: 1851592 · Received September 27, 2010

    Report

    Report Number
    9613350-2010-00465
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    January 11, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVED EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR EXPLANTED 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 THIS EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 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)(4) CONSIDERS THIS CASE CLOSED. (B)(4)

    Description of Event or Problem · 1

    IT IS REPORTED BY PATIENT'S COUNSEL THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6)2007. IT IS ALSO REPORTED THAT POST OP, PATIENT EXPERIENCED PAIN, LOOSENING, AND WAS REVISED ON (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R