BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL HIP SYSTEM COLLARLESS STEM POROUS LEFT

    MDR report key: 1113315 · Received August 12, 2008

    Report

    Report Number
    1822565-2008-00504
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE NATURAL POROUS HIP STEM WAS NOT RETURNED FOR REVIEW. IT IS ALLEGED THAT THE STEM FINISHED PROUD OF THE BROACH THAT WAS USED. NO X-RAYS, PHOTOGRAPHS, OR ADDITIONAL SURGICAL SPECIFICATIONS WERE PROVIDED EXCEPT THE FACT THAT THE PATIENT WAS A SMALL BUILD FEMALE WITH A MEDIUM ACTIVITY LEVEL. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY IN 2008, STEM FINISHED PROUD OF THE BROACH. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL HIP SYSTEM COLLARLESS STEM POROUS LEFT HIP PROSTHESIS KWY ZIMMER, INC. NA 60891494

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK