BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOST STEM DISTRACTOR

    MDR report key: 2062867 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00669
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    October 8, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THE FRACTURED TIP WAS NOT. THE DEVICE HAS A POTENTIAL FIELD AGE OF (B)(4). THE DEVICE APPEARS TO BE IN RELATIVELY GOOD CONDITION, BUT DOES SHOW EVIDENCE OF USE. BASED ON THE AVAILABLE INFORMATION, THE FRACTURE OF THE TIP APPEARS TO BE DUE TO NORMAL USE. HOWEVER, BECAUSE DETAILS SURROUNDING THE FRACTURE OF THE TIP ARE UNKNOWN, AS THIS CONDITION WAS NOTICED BEFORE A SURGERY, THE EXACT ROOT CAUSE OF THE FRACTURE CANNOT BE DETERMINED. 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE TOP PIECE IS BROKEN OFF AND THAT IT WAS DISCOVERED WHILE INSPECTING TRAYS PRIOR TO DELIVERY FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOST STEM DISTRACTOR HIP INSTRUMENT LXH ZIMMER, INC. 60281712

    Patients

    Seq Age Sex Outcome Treatment
    1