BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK CR FLEX FEMORAL COMPONENT

    MDR report key: 1841920 · Received August 31, 2010

    Report

    Report Number
    1822565-2010-00635
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THOUGH BONE CEMENT HAS CLEARLY BEEN APPLIED TO THE FEMUR IN A GENERAL MANNER, IT IS NOT POSSIBLE TO ASCERTAIN IF THE CEMENT WAS APPLIED BEHIND THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT. FURTHER, THE RADIOGRAPHS DO NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE IF OSTEOLYSIS, STRESS SHIELDING OR LOOSENING OF THE FEMORAL COMPONENT HAS OCCURRED. WITHOUT ADDITIONAL INFORMATION, A CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WAS 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 THE PATIENT IS PRESENTING WITH FEMORAL LOOSENING AND BONE RESORBTION OF ANTERIOR CORTEX. THE PATIENT WILL NEED TO BE REVISED FOR PAIN AND LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR