BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT

    MDR report key: 1852426 · Received September 29, 2010

    Report

    Report Number
    1822565-2010-00831
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    May 17, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICE OR X-RAYS WERE RETURNED FOR EVAL. SURGEON NOTES ARE ALSO UNAVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. THE PROBABLE CAUSE OF THE DISLOCATION CANNOT BE DETERMINED WITHOUT THE AVAILABILITY OF X-RAYS AND/OR PRODUCT. EVAL: 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR MULTIPLE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 61113483

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention