BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTIONS STEMMED TIBIAL COMPONENT

    MDR report key: 1231925 · Received November 13, 2008

    Report

    Report Number
    2648920-2008-00054
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVAL. IT IS REPORTED THAT THE ANTERIOR TIBIA CRACKED UPON IMPACTION OF THE REAL IMPLANTS FOR TRIAL. THE CAUSE OF THE PROBLEM COULD NOT BE DEFINITELY DETERMINED DUE TO INSUFFICIENT INFO. EALUATION: NO PRODUCT WAS RETURNED. 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 INFO BE REC'D, THE COMPLAINT WILL BE REOPENED ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008. WHILE THE SURGEON WAS TRAILING WITH COMPONENT THE ANTERIOR TIBIA CRACKED. SURGEON HAD TO CABLE THE PROXIMAL TIBIA BECAUSE OF THE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTIONS STEMMED TIBIAL COMPONENT KNEE PROSTHESIS HSH ZIMMER MANUFACTURING B.V. NA 60983902

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR