BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    MDR report key: 2071737 · Received April 13, 2011

    Report

    Report Number
    9613350-2011-00225
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER DID NOT YET 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. IT IS NOT SUSPECTED THAT THE ALLEGED EVENT WAS CAUSED BY PRODUCT FAILURE. AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE AND / OR THE DEVICE(S) HAVE BEEN RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO CONSTANT PAIN IN THE JOINT SINCE INITIAL SURGERY. DURING REVISION, LARGE LESIONS OF THE SOFT TISSUE HAVE BEEN DETECTED. THERE WAS BLACK SMUDGE IN THE TISSUE. THE RETRIEVALS WILL BE PROVIDED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 54/48 CODE N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2314332

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization