BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 3144936 · Received May 31, 2013

    Report

    Report Number
    1644408-2013-00296
    Event Type
    Other
    Date Received
    May 31, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 AN AGENT INFORMED DJO SURGICAL OF A REVISION SURGERY INVOLVING A REPLACEMENT OF A FOUNDATION KNEE AND SOMBRERO TRI-PEG PATELLA. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE PARTS INVOLVED WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOWED THAT THE REPORTED DEVICES RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE AND WERE WITHIN THEIR EXPIRATION DATES AT THE TIME OF THE ORIGINAL SURGERY. A REVIEW OF THE IMPLANTS DEVICE HISTORY RECORDS, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOWED THAT THIS DEVICE MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. NO INFORMATION WAS SUBMITTED WITH REGARD TO THE SEVERITY OF THE INFECTION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THIS INCIDENT WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD AN INFECTION IN THE KNEE; THE SURGEON REMOVED ALL OF THE ORIGINAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240558 FOUNDATION KNEE ALL-POLY SOMBRERO TRI-PEG PATELLA JWH ENCORE MEDICAL, L.P. 468A1015

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 202-01-104, LOT 731A1037| 380-15-504, LOT 54048944| 324-01-104, LOT 233B1080