BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESURFACING CUP COUPLING HANDLE

    MDR report key: 1924941 · Received December 10, 2010

    Report

    Report Number
    9613350-2010-00580
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE MFR 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 INFO BECOMES AVAILABLE AND / OR THE DEVICE(S) HAVE BEEN RETURNED FOR EVAL AND AN INVESTIGATION RESULT IS 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. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS EXTENDED BY APPROX 45 MINUTES BECAUSE THE CUP HANDLE GOT STUCK MORE THAN 6 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESURFACING CUP COUPLING HANDLE NONE JDI ZIMMER GMBH 08.383327

    Patients

    Seq Age Sex Outcome Treatment
    1 Other