BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 8821381 · Received July 24, 2019

    Report

    Report Number
    1038671-2019-00369
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 9, 2019
    Report Date
    March 31, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION, INITIAL OR PROLONGED. (D2) COMMON DEVICE NAME: TIBIAL PLATE FB SZ 3 LT. (D4) CATALOG NUMBER: 350-11-03. SERIAL NUMBER: (B)(6). EXPIRATION DATE: 03-MAR-2027. UNIQUE IDENTIFIER (UDI) #: (B)(4). (D7) IF EXPLANTED, GIVE DATE: ON (B)(6) 2019. (D11) CONCOMITANT DEVICE(S): 320-10-03, 4704751, ANKLE SZ 3 LOCKING CLIP 350-21-03, 4536743, TIBIAL INSERT FB SZ 3 LT 6MM 350-01-03, 4936041, TALAR IMPLANT SZ 3 LT. (E3) OCCUPATION: PHYSICIAN. (E4) INITIAL REPORTER ALSO SENT REPORT TO FDA?: NO. (G5) PMA/510(K)NUMBER: K152217. (H4) DEVICE MANUFACTURE DATE: 03-MAR-2017. (H6) EVALUATION CODES: 1924, 4002. 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 08-JUL-2019.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF EITHER PATIENT CONDITIONS, THE INITIAL POSITIONING OF THE IMPLANTS DURING THE INDEX SURGERY BASED ON THE X-RAYS PROVIDED, AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, AND/OR A COMBINATION OF THE THREE, WHICH LED TO ASEPTIC (NON-INFECTED) TIBIAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, APPROXIMATELY 2 YEARS POSTOP THE INITIAL IMPLANT, THE PATIENT PRESENTED WITH PAIN. A REVISION WAS COMPLETED AND TIBIAL LOOSENING WAS CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS POSTOP THE INITIAL IMPLANT, THE PATIENT PRESENTED WITH PAIN. A REVISION WAS COMPLETED AND TIBIAL LOOSENING WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    VANTAGE PATIENT PRESENTS PAIN THAT SURGEON THINKS INDICATES LOOSENING OF THE TIBIAL COMPONENT. REVISION SURGERY HAS NOT OCCUR YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614006 VANTAGE TIBIAL PLATE FB SZ 3 LT HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.