BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DKNEE

    MDR report key: 4899112 · Received July 8, 2015

    Report

    Report Number
    1644408-2015-00402
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OIY
    PMA / PMN Number
    K091956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A MALPOSITIONED FOOT AFTER 6 MONTHS, 15 DAYS IN VIVO. THE HEALTHCARE PROFESSIONAL INDICATED 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 MADE AVAILABLE TO (B)(4) FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST THIS PART AND LOT NUMBER. THIS INVESTIGATION IS LIMITED IN SCOPE BECAUSE THE EXPLANTED PRODUCTS WERE NOT RETURNED TO (B)(4) AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE WAS NO INFORMATION REPORTED THAT EVIDENCES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT STATING THAT HIS FOOT TURNED OUTWARD. THE SURGEON DETERMINED THAT THE ROTATION COULD BE CORRECTED AND THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442675 3DKNEE INSERT, 3D EX SZ 8RT 13MM OIY ENCORE MEDICAL, L.P. 59602062

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention