BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 1930678 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01350
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ZIMMER, INC
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: BASED ON SURGICAL NOTES PROVIDED, IT APPEARS THAT THE PT HAD A LOOSE TIBIAL COMPONENT POSSIBLY DUE TO BONY OSTEOLYSIS AND DEVICE SUBSIDENCE. ALSO, CEMENT BONDING ON THE BACK SIDE OF THE TIBIAL COMPONENT WAS INADEQUATE AS OBSERVED DURING REVISION SURGERY. THE X-RAYS PROVIDED WERE OF POOR QUALITY FOR EVALUATION. A SPECIFIC CAUSE OF THE DEVICE LOOSENING CANNOT BE DETERMINED DUE TO UNAVAILABILITY OF ADEQUATE INFORMATION. EVALUATION CODES: 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 IS REPORTED THAT THE PT WAS REVISED FOR A LOOSE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT KNEE PROSTHESIS HSH ZIMMER, INC 60400049

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention