BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LCCK POLYETHYLENE INSERT

    MDR report key: 1884129 · Received October 21, 2010

    Report

    Report Number
    1822565-2010-00970
    Event Type
    Injury
    Date Received
    October 21, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A JOURNAL ARTICLE. EVALUATION SUMMARY: NEITHER DEVICES NOR X-RAYS NOR OPERATIVE NOTES WERE RETURNED FOR EVALUATION. PATIENT INFORMATION SUCH AS HEIGHT, WEIGHT, AND ACTIVITY LEVEL IS UNKNOWN. WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: 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 IS REPORTED THAT THE PATIENT WAS REVISED FOR A LARGE EFFUSION, AN AUDIBLE CLUNK AS THE KNEE WAS EXTENDED FROM THE FLEXED POSITION, AND X-RAYS DEMONSTRATED THAT THE LOCKING SCREW HAD DISENGAGED AND MIGRATED PROXIMALLY INTO THE ANTERIOR KNEE JOINT. FURTHERMORE, THE INSERT HAD DISENGAGED FROM THE PERIPHERAL LOCKING MECHANISM AND LIFTED SLIGHTLY FROM THE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEXGEN LCCK POLYETHYLENE INSERT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention