BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER BONE CEMENT INJECTOR

    MDR report key: 1728508 · Received May 14, 2010

    Report

    Report Number
    1822565-2010-00306
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    July 19, 2006
    Report Date
    July 27, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    KIH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER INC. CONSIDERS THE INVESTIGATION CLOSED. EXEMPTION: (B)(4). TOTAL # OF EVENTS: 2. TYPE OF EVENT: MALFUNCTION. PRODUCT CODE: KIH. REASON FOR EXEMPTION: THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS DISCOVERED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE INJECTING CEMENT, THE NOZZLE OF THE GUN BROKE OFF WHILE IN THE FEMORAL CANAL, THE PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER BONE CEMENT INJECTOR BONE CEMENT INSTRUMENT KIH ZIMMER, INC. NA 60013323

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR