BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT

    MDR report key: 3042084 · Received April 4, 2013

    Report

    Report Number
    1822565-2013-00601
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RECEIVED; HOWEVER, PHOTOGRAPHS OF THE EXPLANTED DEVICES WERE RECEIVED FROM THE COMPLAINANT. ONE IMAGE APPEARS TO SHOW THE UNICOMPARTMENTAL FEMORAL BEING REMOVED IN TWO PIECES FROM THE SURGICAL SITE. ANOTHER IMAGE APPEARS TO SHOW THE TWO PARTS OF THE FRACTURED UNICOMPARTMENTAL FEMORAL WITH ADHERING BONE CEMENT ON BOTH PIECES; THE DEVICE APPEARS TO HAVE BEEN FRACTURED APPROXIMATELY IN HALF, WITH A POST ON EACH HALF. A THIRD IMAGE APPEARS TO SHOW THE OPPOSITE SIDES OF THE TWO PIECES. X-RAYS AND SURGICAL NOTES WERE NOT PROVIDED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, POSSIBLE TRAUMA, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 DUE TO A BROKEN FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139213 ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT HSX ZIMMER, INC. 61189225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention