BEUDAMED
    FDA Adverse Event Summary report: N

    ZNN CMN LAG SCREW 10.5X90

    MDR report key: 2132249 · Received June 1, 2011

    Report

    Report Number
    9613350-2011-00342
    Date Received
    June 1, 2011
    Date of Event
    March 15, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT 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. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. AS SOON AS ADD'L INFO HAS BECOME AVAILABLE AND / OR THE DEVICE(S) HAVE BEEN RETURNED FOR EVAL AND AN INVESTIGATION RESULT HAS BECOME AVAILABLE, 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). PLEASE NOTE THAT FOR THIS ZIMMER COMPLAINT CASE, THERE ARE TWO MDRS FILED BECAUSE TO DIFFERENT SCREWS ARE INVOLVED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS EXTENDED BY 2 HOURS BECAUSE A FIXING PROBLEM WITH THE 90MM LAG SCREW HAS OCCURRED. IT HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CMN LAG SCREW 10.5X90 ZIMMER UNIVERSAL LOCKING SYSTEM HRS ZIMMER GMBH 2547132

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other