BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-OP STANDARD INSERT

    MDR report key: 1150088 · Received August 29, 2008

    Report

    Report Number
    1822565-2008-00562
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED. THIS ITEM NUMBER IS FOR A CUSTOM PRODUCT, THEREFORE, A BASELINE REPORT CANNOT BE FILED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1998. THE SITE REPORTS THAT AT 10 YEARS POST-OP, PATIENT HAD COMPLICATION OF 2MM POLYETHYLENE LINER WEAR ON THE OPERATIVE HIP. PATIENT IS TOLERATING THE COMPLICATION, NO REVISION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTER-OP STANDARD INSERT HIP PROSTHESIS KWY ZIMMER, INC. NA 1309340

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR