BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 48/42 CODE H

    MDR report key: 2032573 · Received March 15, 2011

    Report

    Report Number
    9613350-2011-00155
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN THE (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. AS SOON AS ADDITIONAL INFORMATION HAS BECOME AVAILABLE AND / OR THE DEVICE(S) WERE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AND AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION SURGERY DUE TO PAIN. SURGERY REVEALED METAOSIS, A SUBFASCIAL CYST FILLED WITH GREYISH FLUID. THE CUP WAS NOT LOOSE. INITIAL SURGERY WAS ON (B)(6)-2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 48/42 CODE H DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2425972

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization