BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 22015037 · Received May 13, 2025

    Report

    Report Number
    1038671-2025-02053
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 29, 2025
    Report Date
    September 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D9, H6, HLL. THE COMPLAINT DEVICE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. THE LINER-PLATE ARTICULATING SURFACE APPEARS TO HAVE PITTING AND SCRATCHING CONSISTENT WITH CONTACT WITH A THIRD BODY. THE POSTERIOR AND ANTERIOR EDGES OF THE LINER APPEAR TO HAVE BURNISHING. THE LINER-TALUS ARTICULATING SURFACE APPEARS TO HAVE MILD SCRATCHING CONSISTENT WITH CONTACT WITH A THIRD BODY. THERE APPEARS TO BE SUBSURFACE DAMAGE NEAR THE FRACTURE SITE OF THE POSTERIOR PORTION OF THE LINER WHICH APPEARS CONSISTENT WITH HIGH IN-VIVO LOADING. NOTE THAT THE DAMAGE DOES NOT PROPAGATE TO THE ANTERIOR PORTION OF THE LINER. THE POSTERIOR SECTION APPEARS GROSSLY DEFORMED ON ITS SUPERIOR SURFACE, MEDIAL AND LATERAL WALLS, AND ITS MEDIAL CONDYLE. THE ANTERIOR SECTION OF THE LINER APPEARS TO HAVE STRESS WHITENING ON THE MEDIAL SIDE CONSISTENT WITH HIGH IN-VIVO LOADING ON THE MEDIAL SIDE. NOTE THAT THE ANTERIOR SECTION OF THE LINER DOES NOT APPEAR GROSSLY DEFORMED AS THE POSTERIOR PORTION. THIS MAY INDICATE THAT THE POSTERIOR SECTION OF THE LINER WAS ARTICULATING WITH, OR PINCHED BETWEEN THE TIBIA AND TALUS COMPONENTS POST-FRACTURE. THERE APPEARS TO BE A FRACTURE SITE LINE. THERE WAS DEFORMATION ON THE POSTERIOR SECTION OF THE LINER. THE POSTERIOR MEDIAL CORNER OF THE LINER APPEARS TO HAVE AN AREA OF SUBSURFACE DAMAGE, WHICH APPEARS CONSISTENT WITH UNEVEN LOADING. IT IS UNCLEAR IF THIS WAS A BYPRODUCT OF THE LINER INSERTION STEP, THE FRACTURE, OR HIGH LOADING DURING DORSIFLEXION. THE PROVIDED RADIOGRAPHS WERE TAKEN TWO WEEKS PRIOR TO THE REPORTED REVISION. THE CALCANEOUS APPEARS TO BE MISALIGNED WHEN COMPARED TO THE NORMAL ACCEPTED ALIGNMENT OF 0-6 DEGREES OF VALUS. HOWEVER, THIS MAY BE A RESULT OF A NON-WEIGHT BEARING RADIOGRAPH, AND/OR THE VIEWING ANGLE. THIS MAY HAVE CONTRIBUTED TO UNEVEN LOADING. THERE APPEARS TO BE ABNORMAL BONE PROTRUSIONS ON THE ANTERIOR AND POSTERIOR OF THE TIBIA AND THE TALUS AT THE HEIGHT OF THE TALAR FLANGE. BASED ON THE POST-IMPLANT RADIOGRAPHS, THIS MAY BE INDICATIVE OF HETEROTOPIC OSSIFICATION. THE POSITION OF THE LINER RADIOGRAPHIC MARKER APPEARS CONSISTENT WITH THE TIBIA AND TALUS PINCHING THE LINER. ALL OTHER ASPECTS OF THE DEVICES APPEAR UNREMARKABLE. A REVIEW OF MANUFACTURING DATA WAS PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REVISION REPORTED WAS LIKELY A COMBINATION OF PREFERENTIAL MEDIAL LOADING AND PATIENT RELATED CONDITIONS, WHICH LEAD TO WEAR, CRACK INITIATION AND PROPAGATION, AND SUBSEQUENT LINER FRACTURE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 350-01-01E - TALUS - LEFT - SZ 1 - EU, (B)(6), 350-31-02 - TIBIAL PLATE MB SZ 2 LT. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD COMPLAINTS OF PAIN. FOLLOWING A RX EXAMINATION OF THE PATIENT¿S LEFT ANKLE, THE SURGEON DECIDED TO REMOVE THE TIBIAL INSERT. FOLLOWING THE INCISION, THE LINER WAS REMOVED DUE TO THE FACT IT WAS BROKEN. ALL PARTS AND PIECES WERE REMOVED. THE TIBIAL AND TALAR COMPONENTS HAD GOOD STABILITY. THERE WAS A 1 TO 30 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO IMPACT TO THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182950 VANTAGE PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SEE H11.