BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ROTATING HINGE KNEE FEMORAL COMP

    MDR report key: 2092797 · Received May 11, 2011

    Report

    Report Number
    1822565-2011-01158
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE FEMORAL COMPONENT HAS BOTH AUGMENTS AND THE STEM EXTENSION ATTACHED. THE FEMORAL COMPONENT HAS A LOT OF GOUGING AND SCRATCHING ON IT. THERE IS HEAVY DAMAGE TO THE INSERTION/EXTRACTION SLOTS AND TO THE FLANGE. THERE IS ALSO A LOT OF SCRATCHING ON THE RIGHT CONDYLE ON THE MEDIAL SIDE. THE POLY BOX INSERT HAS A LOT OF SCRATCHING ON IT AS WELL. THE SUPERIOR PORTION OF IT IS BENT UPWARDS. THE THREADS ARE STRIPPED AND THERE ARE SCRATCHES AROUND THE SHAFT. ALL FOUR AUGMENTS HAD GOUGES ON THE PORTIONS THAT COULD BE SEEN. THE REPORTER NOTED THAT IT APPEARED THE POST EXTENSION PULLED THROUGH THE HINGE. MEASUREMENTS WERE TAKEN AND THE POST EXTENSION HAS A GREATER DIAMETER THAN THE HINGE POST SO THIS COULD NOT HAVE OCCURRED. (B)(6) NOTES WERE NOT PROVIDED SO IT IS UNKNOWN WHETHER THE PROPER TECHNIQUE WAS FOLLOWED. WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN (B)(6) 2010 AND THAT THE PATIENT WAS REVISED DUE TO DISSOCIATED RH KNEE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ROTATING HINGE KNEE FEMORAL COMP KRO ZIMMER, INC. 60940849

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention