BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 4155348 · Received October 7, 2014

    Report

    Report Number
    2648920-2014-00262
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: OPERATIVE NOTES ARE NOT RETURNED FOR REVIEW. TWO VERY POOR QUALITY X-RAYS ARE PROVIDED, WHICH DO NOT ALLOW FOR VISUAL ANALYSIS. THE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNKNOWN. THE PATIENT'S ACTIVITY AT THE TIME OF THE DISLOCATIONS ARE UNKNOWN. 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. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY UNREPORTED TRAUMATIC EVENT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: 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 WAS REVISED DUE TO MULTIPLE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626415 VERSYS FEMORAL HEAD LPH ZIMMER 24330400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention TRILOGY LONGEVITY POLY LINER| CATALOG: 00632005028, LOT: 78585700| MFR BY ZIMMER (B)(4).