BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 8662927 · Received June 3, 2019

    Report

    Report Number
    1038671-2019-00321
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 17, 2019
    Report Date
    October 18, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276223
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (E3) OCCUPATION: PHYSICIAN (G5) PMA/510(K)NUMBER: K152217 (H3) IT WAS REPORTED THAT A 58 YEAR OLD, WEIGHT IS 257 LBS PATIENT RECEIVED A POLY SWAP AND GUTTER DEBRIDEMENT. BONY OVERGROWTH LIMITED ROM SOMETIME IN THE MIDDLE OF MAY 2019. IT WAS ALSO REPORTED THAT THE DEVICES WILL NOT BE RETURNED BUT THE POLY AND IMPLANT DID NOT HAVE SIGNIFICANT WEAR. THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON REVIEW, THERE IS NO INDICATION OF MANUFACTURING OR DESIGN ISSUES. THE MOST LIKELY CAUSE OF THE REPORTED EVENT MAY HAVE BEEN THE RESULT OF BONY OVERGROWTH CAUSING LIMITED RANGE OF MOTION, PATIENT CONDITIONS, OR A COMBINATION OF THE TWO, WHICH LED TO LIMITED RANGE OF MOTION, HOWEVER: THIS CANNOT BE CONFIRMED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A3, A5, B6, B7, D7, G8, H4, H6, H7 SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 17-MAY-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE: 350-10-03, SIZE 3 LOCKING CLIP.

    Description of Event or Problem · 1

    POLY SWAP AND GUTTER DEBRIDEMENT. BONY OVERGROWTH LIMITED ROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457405 VANTAGE TIBIAL INSERT FB SZ 2 LT 6MM HSN EXACTECH, INC. 10885862276223

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention