BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS) FEMORAL

    MDR report key: 1316194 · Received December 11, 2008

    Report

    Report Number
    1822565-2008-00899
    Event Type
    Malfunction
    Date Received
    December 11, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ZIMMER HELD A TELECONFERENCE WITH THE DR ON DECEMBER 1, 2008 TO DISCUSS HIS OBSERVATIONS. DR FELT THAT THIS OBSERVATION WAS NEW TO HIS PRACTICE AND WANTED TO SHARE THIS INFORMATION WITH ZIMMER. THE PATIENT WAS ASYMPTOMATIC AND DR WILL WATCH FOR POSSIBLE PROGRESSION OF LUCENCY. EVALUATION CODES: 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 INITIAL POSTOPERATIVE X-RAYS WERE PERFECT WITH FULL APPOSITION OF THE ANTERIOR FEMORAL CORTEX TO THE FEMORAL FLANGE. AT ONE TO TWO YEARS THESE PATIENTS, ARE ASYMPTOMATIC HAVING A DISTINCT RADIOLUCENCY. THERE IS A SCLEROTIC ANTERIOR FEMORAL MARGIN, RECESSED TWO MILLIMETERS FROM THE FEMORAL METAL. IMPLANT DATE IS UNKNOWN. IT IS UNKNOWN WHETHER THE PATIENT HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS) FEMORAL KNEE PROSTHESIS HSA ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK