BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2133536 · Received June 15, 2011

    Report

    Report Number
    1822565-2011-01418
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 2, 2010
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THE REASON FOR THE PROCEDURE WAS TO EXPLORE PROSTHESIS LOOSENING. THE STUDY INDICATED LOOSENING. THE CONCLUSION WAS BASED ON ASYMMETRIC UPTAKE IN THE RIGHT MEDIAL FEMORAL CONDYLE WHEN COMPARED TO THE LEFT. THE SURGICAL NOTES FROM WHEN THE DEVICES WERE IMPLANTED DID NOT INDICATE ANY COMPLICATIONS. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. 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 REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT STUDY VIA INTRAVENOUS FLUID TO RULE OUT PROSTHESIS LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60854135

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other