BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER RHK KNEE FEMORAL COMPONENT

    MDR report key: 1063136 · Received June 20, 2008

    Report

    Report Number
    1822565-2008-00342
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A SIZE F RHK KNEE FEMORAL COMPONENT WAS REVISED. THE SALES REPRESENTATIVE DESCRIBED A FAILURE OF THE HINGE MECHANISM WHICH OCCURRED APPROXIMATELY 6 WEEKS POST-OP IN A PATIENT WITH A HISTORY OF MULTIPLE REVISIONS. THE TIME BETWEEN FAILURE AND REVISION AS WELL AS DETAILS OF THE EXACT NATURE OF THE FAILURE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER RHK KNEE FEMORAL COMPONENT KNEE PROSTHESIS HSA ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R