BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2013378 · Received March 8, 2011

    Report

    Report Number
    1822565-2011-00531
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCTS WERE RETURNED, AS THEY WERE IMPLANTED EXPIRED IN THE PATIENT. ROOT CAUSE OF EVENT IS USE AFTER THE EXPIRATION DATE. EVALUATION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ARTICULAR SURFACE WAS OPENED IN SURGERY, IT WAS NOTED THE IMPLANT'S EXPIRATION DATE OF (B)(6) 2011 HAD PASSED. THE COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 60423545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other