BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 2887056 · Received December 20, 2012

    Report

    Report Number
    1822565-2012-02602
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: X-RAY EVALUATION NOTES STATE THAT THERE IS NO EVIDENCE OF LOOSENING AND NO CHANGE FROM AN X-RAY TAKEN IN (B)(6) 2009. BONE SCAN RESULTS INDICATE MILD TO MODERATE UPTAKE SEEN ABOUT THE PROXIMAL AND DISTAL ASPECTS OF THE LEFT FEMORAL STEM. IN GENERAL, PATIENT COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. AN EXACT ROOT CAUSE CANNOT BE STATED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCED PAIN. PROGRESS NOTES STATE THAT THE STEM IS LOOSE AND A REVISION SURGERY IS IN DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER FEMORAL STEM LZO ZIMMER INC 60939242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other