BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR ARTICULAR SURFACE

    MDR report key: 2042213 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00554
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 22, 2010
    Report Date
    February 24, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO PACKAGING OR "HAIR" WAS RETURNED. EVIDENCE MARKS ON MEDIAL, LATERAL AND POSTERIOR SIDES OF THE IMPLANT APPEAR TO SHOW IMPLANT WAS ATTEMPTED FOR USE. THE IMPLANT WAS RETURNED, HOWEVER, THE PACKAGING WHERE THE HAIR WAS FOUND WAS NOT. IT WAS NOT INDICATED IN WHICH PORTION OF THE PACKAGING (INNER CAVITY, OUTER CAVITY, ETC.) THE HAIR WAS FOUND. THERE IS A CERTIFICATE OF PROCESSING FROM STERIGENICS WHICH STATES THIS LOT OF IMPLANTS WAS STERILIZED AT A MINIMUM DOSAGE OF 27.0 KGY AND A MAXIMUM DOSAGE OF 35.2 KGY. PER ZWI 36.210, THE MINIMUM DOSAGE MUST BE OVER 25.0 KGY AND THE MAXIMUM DOSAGE MUST BE UNDER 37.0 KGY. THEREFORE, THIS LOT OF IMPLANTS IS STERILE. 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 A BLACK HAIR WAS FOUND ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR ARTICULAR SURFACE JWH ZIMMER INC. 60878194

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR