BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FB SZ 3 RT 10MM

    MDR report key: 16736571 · Received April 13, 2023

    Report

    Report Number
    1038671-2023-00678
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    July 22, 2022
    Report Date
    April 17, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862293275
    PMA / PMN Number
    K152217
    Removal / Correction Number
    Z-0024-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6, INVESTIGATION-BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE PATIENT 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. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: SERIAL#: (B)(4), CATEGORY#: 350-02-03 - TALAR IMPLANT SZ 3 RT, SERIAL#: (B)(4), CATEGORY#: 350-10-04 - ANKLE SZ 4 LOCKING CLIP, SERIAL#: (B)(4), CATEGORY#: 350-12-04 - TIBIAL PLATE FB SZ 4 RT.

    Description of Event or Problem · 0

    LEGAL CASE: (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT, A 62 YEAR OLD MALE, IS VERIFIED RIGHT ANKLE ON (B)(6) 2018 AND A RIGHT ANKLE REVISION ON (B)(6) 2022, APPROXIMATELY 3 YEARS AND 11 MONTHS AFTER THEIR INITIAL SURGERY. POSTOPERATIVE DIAGNOSIS: PAINFUL RIGHT TOTAL ANKLE REPLACEMENT, PERIPROSTHETIC CYST UNDERNEATH THE TALUS. INSPECTION OF THE POLYETHYLENE DEMONSTRATED NO EVIDENCE OF FRACTURE OR DELAMINATION. THE TIBIA AND TALAR COMPONENTS WERE INSPECTED AND WERE STABLE. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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. SERIAL#: (B)(4), CATEGORY#: 350-22-43 - TIBIAL INSERT FB SZ 3 RT 10MM, SERIAL NUMBER: (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K152217. CONCOMITANTS: SERIAL#: (B)(4), CATEGORY#: 350-02-03 - TALAR IMPLANT SZ 3 RT, SERIAL#: (B)(4), CATEGORY#: 350-10-04 - ANKLE SZ 4 LOCKING CLIP, SERIAL#:(B)(4), CATEGORY#: 350-12-04 - TIBIAL PLATE FB SZ 4 RT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479401 TIBIAL INSERT FB SZ 3 RT 10MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. TIBIAL INSERT FB SZ 3 RT 10MM UNK 10885862293275

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H10.