BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTESION PI

    MDR report key: 1561185 · Received December 16, 2009

    Report

    Report Number
    1822565-2009-01202
    Event Type
    Injury
    Date Received
    December 16, 2009
    Date of Event
    February 10, 2005
    Report Date
    November 16, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVAL. ALSO, NO X-RAYS WERE RETURNED FOR REVIEW. PT INFO SUCH AS HEIGHT, WEIGHT, AND PT ACTIVITY IS UNK. BASED ON THE AVAILABLE INFO, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, 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 DEVICE WAS IMPLANTED IN 2004 AND THAT THE PATIENT WAS REVISED IN 2005 DUE TO A SNAPPING-PHENOMENON, SUBLUXATION, DISLOCATION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTESION PI KNEE PROSTHESIS HRZ ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R