BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2060961 · Received March 14, 2011

    Report

    Report Number
    1822565-2011-00573
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    September 28, 2009
    Report Date
    October 8, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE IMPLANT WAS RETURNED, HOWEVER THE PACKAGING WHERE THE HAIR WAS FOUND WAS NOT. IT WAS NOT KNOWN WHICH PORTION OF THE PACKAGING (INNER CAVITY, OUTER CAVITY, ETC.) THE HAIR WAS FOUND. REGARDLESS, THERE IS A CERTIFICATE OF PROCESSING FROM STERIGENICS WHICH STATES THIS LOT OF IMPLANTS WAS STERILIZED AT A MINIMUM DOSAGE OF 26.4 KGY AND A MAXIMUM DOSAGE OF 33.4 KGY. PER ZWI 36.210, THE MINIMUM DOSAGE MUST BE 25.0 KGY AND THE MAXIMUM DOSAGE MUST BE 37.0 KGY. THEREFORE, THIS LOT OF IMPLANTS ARE STERILE. ADDITIONALLY, ANY FOREIGN SUBSTANCES RECEIVING THAT DOSAGE OF GAMMA IRRADIATION WOULD ALSO BE STERILE, INCLUDING THE HAIR. SINCE THE HAIR IS STERILE, THERE ARE NO ADDITIONAL RISKS INTRODUCED TO THE PATIENT. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 SURGICAL SCRUB NURSE FOUND A HAIR INSIDE STERILE PACK OF IMPLANT. IT WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61277545

    Patients

    Seq Age Sex Outcome Treatment
    1