BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER IMPACTOR HANDLE

    MDR report key: 1930286 · Received October 5, 2010

    Report

    Report Number
    1822565-2010-00837
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 22, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION SUMMARY: THE ITEM NUMBER AND LOT NUMBER OF THE IMPACTOR HANDLE USED WITH THE POSITIONER HEAD IS UNKNOWN. THE TENTATIVE FIELD AGE OF THE POSITIONED HEAD IS 22 YRS. ONE OR A COMBINATION OF THE FOLLOWING FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURE: INSUFFICIENT THREAD ENGAGEMENT DURING IMPACTION MAY HAVE LED TO HIGH STRESS ON THE THREADS AND SUBSEQUENT FAILURE; OFF-AXIS IMPACTION OF THE COMPONENT EITHER WITH SUFFICIENT OR INSUFFICIENT THREAD ENGAGEMENT; THE DEVICE WAS INADVERTENTLY DROPPED OR DAMAGED DURING CLEANING/AUTOCLAVE. HOWEVER, NO DEFINITIVE CAUSE ANALYSIS CAN BE PERFORMED WITH CERTAINTY. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND LOT NUMBER REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING LEFT TOTAL HIP ARTHROPLASTY BEING PERFORMED ON A PATIENT WITH AVASCULAR NECROSIS, THE HEAD OF A ZIMMER IMPACTOR BROKE OFF FROM HANDLE. THE SCREW HOLDING THE FLAT ROUND HEAD ON THE HANDLE APPEARED TO BE BROKEN. X-RAYS TAKEN AND NO METAL FRAGMENTS WERE NOTED TO BE RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER IMPACTOR HANDLE HIP INSTRUMENT LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR