BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM PRIMARY HIP FEMORAL STEM PRESS-FIT

    MDR report key: 1940549 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01389
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE CONDITION OF THE FEMORAL STEM IS UNKNOWN. IT IS ALSO UNKNOWN IF IT WAS IMPLANTED TO THE PROPER FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE. DIFFERENCES IN THE MATERIAL PROPERTIES BETWEEN THE IMPLANT AND THE SURROUNDING BONE CAUSE STRESS CONCENTRATIONS WHICH INCREASE THE LIKELIHOOD OF BONE FRACTURE IN THE EVENT OF TRAUMA. THE MOST LIKELY CAUSE OF THIS FRACTURE IS THE FALL EXPERIENCED BY THE PT. EVAL: THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE CONFORMING TO THE MFG, INSPECTION, AND PACKAGING SPECIFICATIONS. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE AFTER EXPERIENCING A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM PRIMARY HIP FEMORAL STEM PRESS-FIT HIP PROSTHESIS KWY ZIMMER, INC. 61530979

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention