BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER HIP FEMORAL STEM

    MDR report key: 2153293 · Received June 30, 2011

    Report

    Report Number
    1822565-2011-01544
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    December 30, 2010
    Report Date
    June 3, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXACT CAUSE OF THE REVISION IS UNKNOWN. THE OPERATIVE REPORT FROM WHEN THE STEM WAS IMPLANTED DID NOT DETAIL ANY PATIENT COMPLICATIONS DURING SURGERY. AT THE TIME OF REVISION, THE IMPLANTS HAD BEEN IN VIVO FOR APPROXIMATELY 2.5 YEARS. THE OPERATIVE NOTES INDICATED THAT THE HIP STABILITY WAS OUTSTANDING. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE MANUFACTURING RECORDS FOR THE STEM WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER HIP FEMORAL STEM LPH ZIMMER, INC. 60876622

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention