BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOCH FULL COAT FIBER METAL FEMORAL STEM

    MDR report key: 2003829 · Received February 24, 2011

    Report

    Report Number
    1822565-2011-00397
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    October 12, 2010
    Report Date
    January 28, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE SURGICAL NOTES FROM THE PRIMARY SURGERY WERE RECEIVED. THE SURGICAL NOTES DESCRIBED AN UNEVENTFUL PRIMARY SURGERY WITH POSITIVE ASSESSMENTS MADE IN REGARD TO LEG LENGTH, CUP POSITION AND ROM. PAIN CAN BE CAUSED FOR A VARIETY OF REASONS, SUCH AS: DISLOCATION OF THE JOINT, INFECTION, SOFT TISSUE IMPINGEMENT, PSEUDO TUMORS DUE TO PARTICULATE DEBRIS, LEG LENGTH/OFFSET DISCREPANCY, LOOSENING OF THE PROSTHESIS, AND FRACTURE/BREAKAGE OF THE PROSTHESIS. WITH THE INFORMATION CURRENTLY PROVIDED NO CAUSE FOR PAIN IN THIS PATIENT CAN BE FOUND. FURTHER, NO DESIGN DEFICIENCY CAN BE IDENTIFIED. 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 WAS REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOCH FULL COAT FIBER METAL FEMORAL STEM LPH ZIMMER, INC. 60606395

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention