BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL COCR HEAD 38/ -4 S 12/14

    MDR report key: 2081385 · Received April 29, 2011

    Report

    Report Number
    9613350-2011-00287
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 YET RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D 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) HAVE BEEN RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AN 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 SURGERY (THA) WAS DELAYED BY 1 HOUR SINCE THE DEVICES TURNED OUT TO BE DAMAGED WHEN THE NURSE OPENED THAT STERILE SEAL DURING SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASUL COCR HEAD 38/ -4 S 12/14 DURASUL COBALT CHROME FEMORAL HEAD KWA ZIMMER GMBH 2531102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other