BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN KNEE INSTRUMENT

    MDR report key: 2960312 · Received February 8, 2013

    Report

    Report Number
    1822565-2013-00270
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED; HOWEVER, PHOTOGRAPHS WERE PROVIDED WHICH SHOWED THAT ONE OF THE FEET WAS CRACKED. IT IS NOT KNOWN WHEN THE DEVICE WAS MANUFACTURED, HOW LONG IT WAS IN SERVICE, HOW MANY TIMES IT WAS USED, OR HOW IT MAY HAVE BEEN STORED OR STERILIZED. IT IS LIKELY THAT THE DEVICE HAD EXCEEDED ITS USEFUL LIFE. ZIMMER MANUAL ORTHOPAEDIC SURGICAL INSTRUMENTS DESCRIBED RECOMMENDATIONS FOR CARE, CLEANING, MAINTENANCE, AND STERILIZATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, 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 WAS NOTICED THAT THE BASE OF THE TRAY WAS CRACKED AFTER THE PT WAS PLACED UNDER ANESTHESIA. SURGERY WAS ABORTED DUE TO THE RISK OF POOR STERILIZATION OF THE TRAY. CRACKING OF THE TRAYS HAS ALLEGEDLY BEEN PREVIOUSLY NOTED AN UNKNOWN AMOUNT OF TIMES BY THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54257 UNKNOWN NEXGEN KNEE INSTRUMENT KNEE INSTRUMENT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other