BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURASUL ALPHA INSERT NEUTRAL

    MDR report key: 2130684 · Received June 1, 2011

    Report

    Report Number
    9613350-2011-00333
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(6). THE MANUFACTURER DID NOT YET RECEIVE COMPLAINT DEVICE, 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 DEVICE FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGED 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. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS DELAYED BY 30 MINUTES BECAUSE THE LINER COULD NOT BE INSERTED INTO THE CUP (LINER SEEMED TO BE TOO SMALL). SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASUL ALPHA INSERT NEUTRAL ALLOFIT ACETABULAR SYSTEM KWB ZIMMER GMBH 2360789

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other