BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FB SZ 1 LT 6MM

    MDR report key: 17663653 · Received August 31, 2023

    Report

    Report Number
    1038671-2023-02121
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    October 14, 2022
    Report Date
    May 29, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276216
    PMA / PMN Number
    K152217
    Removal / Correction Number
    Z-0024-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 6192676, 350-03-01 - FLAT CUT TALUS SZ 1 L. 5805048, 350-10-02 - ANKLE SZ 2 LOCKING CLIP. 5810672, 350-11-02 - TIBIAL PLATE FB SZ 2 LT. 5653779, 351-90-20 - TUBERCLE PIN POUCH. 6172437, 351-90-21 - 3.5" PIN POUCH. 6130656, 351-90-22 - 2.5" PIN POUCH. 371714, 351-91-03 - RECIP SAWBLADE 8X50X1MM. 339764, 351-91-04 - SAW-10X75X1.19-STRYKER.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION ¿ B5, D5, H6 MEDICAL DEVICE PROBLEM CODE. H3. INVESTIGATION RESULTS- THE TIBIAL INSERT FB SZ 1 LT 6MM WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THE PATIENT HAS RIGHT ANKLE ISSUES, ALL BIOMECHANICAL ISSUES CAN AFFECT THE STRESSORS ON THE LEFT ANKLE POSSIBLY TO CAUSE PAIN. AS PART OF THE PRE-OPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR POSTOPERATIVE PERIOD. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT ANKLE REPLACEMENT ON (B)(6) 2019 DUE TO END-STAGE ARTHRITIS, LEFT ANKLE, AND CYSTIC FORMATION, LEFT TALUS. THEY UNDERWENT LEFT ANKLE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 3 YEARS 1 MONTH POST PRIMARY PROCEDURE. IN REVISION OP REPORT, THE SURGEON NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF SCAR TISSUE FORMATION AT THE ANTERIOR ASPECT OF THE ANKLE JOINT WITH SIGNIFICANT INVAGINATION INTO THE JOINT AND MEDIAL AND LATERAL ANKLE GUTTERS. THERE WAS SMALL BONE GROWTH OVER THE ANTERIOR ASPECT OF THE TIBIAL TRAY. THERE IS SIGNIFICANT AMOUNT OF FIBROTIC SCAR TISSUE NOTED ALONG THE MEDIAL AND LATERAL ASPECTS OF THE ANKLE JOINT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    PREOPERATIVE DIAGNOSIS: 1: PRESENCE OF ARTIFICIAL ANKLE IMPLANT 2: SYNOVITIS LEFT ANKLE- 3: PAIN LEFT ANKLE 4: COMPLICATION OF INTERNAL HARDWARE LEFT ANKLE 5: POSTTRAUMATIC ARTHRITIS RIGHT FOOT/ THE PATIENT WAS REVISED TO COMPETITOR'S DEVICES. PROPHYLACTIC FIXATION MEDIAL MALLEOLUS LEFT ANKLE. THE PATIENT TOLERATED PROCEDURES AND ANESTHESIA WELL WITH VITAL SIGNS STABLE AND VASCULAR STATUS INTACT TO THE SURGICAL LIMB. THE PATIENT WAS ESCORTED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603627 TIBIAL INSERT FB SZ 1 LT 6MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. UNK 10885862276216

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention