BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 38MM DIA.

    MDR report key: 4841608 · Received June 9, 2015

    Report

    Report Number
    3005751028-2015-00074
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    February 27, 2015
    Report Date
    August 10, 2015
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE MANUFACTURING LOT NUMBER WAS NOT REPORTED, HOWEVER, THE DEVICE HISTORY RECORD FOR ALL DEVICES IS REVIEWED PRIOR TO SHIPPING THE DEVICE FROM THE TMT FACILITY. ADDITIONALLY, THE TM PATELLA WAS NOT RETURNED FOR EVALUATION AS IT WAS RETAINED BY THE SURGEON. THE TM PATELLA IN THIS EVENT WAS FOUND TO BE COMPATIBLE WITH THE FEMORAL COMPONENT THAT WAS IMPLANTED. THE TM PATELLA IS NOT REPORTED TO HAVE FAILED BUT WAS REVISED AS PART OF A STAGE 1 TOTAL KNEE REVISION AS A RESULT OF INFECTION. AS REPORTED, THE SURGEON PROVIDED PHOTOGRAPHS TO ILLUSTRATE HOW WELL BONE INGROWTH OCCURRED IN SPITE OF THE INFECTION. BASED UPON THESE PHOTOGRAPHS, THE TM PATELLA APPEARS ENTIRELY INTACT AND APPEARS TO HAVE PERFORMED AS INTENDED. THIS INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME; HOWEVER, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT SHALL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DEVELOPED AN INFECTION APPROX 7 MONTHS AFTER THE TM PATELLA WAS IMPLANTED. THE TM PATELLA WAS IMPLANTED ON (B)(6) 2014 AND REVISED ON (B)(6) 2015. ADDITIONALLY IT WAS NOTED THAT THE SURGEON REMOVED THE IMPLANT IN STAGE I REVISION AND WANTED TO PROVIDE ZIMMER WITH FEEDBACK ON HOW WELL BONE INGROWTH HAD OCCURRED UNDER THE CIRCUMSTANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION APPROXIMATELY 7 MONTHS AFTER THE TM PATELLA WAS IMPLANTED. THE TM PATELLA WAS IMPLANTED ON (B)(6) 2014 AND REVISED ON (B)(6) 2015. ADDITIONALLY, IT WAS NOTED THAT THE SURGEON REMOVED THE IMPLANT IN STAGE I REVISION AND WANTED TO PROVIDE ZIMMER WITH FEEDBACK ON HOW WELL BONE INGROWTH HAD OCCURRED UNDER THE CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370734 POROUS NEXGEN TM PATELLA, 38MM DIA. TM PATELLA JWH ZIMMER TMT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention