BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 9368550 · Received November 25, 2019

    Report

    Report Number
    1038671-2019-00580
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    November 10, 2019
    Report Date
    February 11, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    PMA / PMN Number
    K080980
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D11) CONCOMITANT DEVICES: BIOLOX DELTA ACETABULAR LINER 36/56-58 - (CAT# 111-22-1010 / SN# (B)(6)). LOGICAL CUP - 3 HOLES, 56MM - (CAT# 111-12-3356 SN# (B)(6)). FEMORAL HEAD CERAMIC 36M (CAT# 111-152-632 / SN# (B)(6)). NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, B6, THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO: D1, D2, D4 (CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, EXP DATE) , D11, G4, G7, H1, AND H4. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (D1) BRAND NAME. (D2) COMMON DEVICE NAME. (D4) (CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, EXP DATE). (G4) 510K NUMBER. (D11) CONCOMITANT DEVICES. (H4) MANUFATURE DATE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION NOTED THAT UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED MALFUNCTION AND THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS AN SURGEON'S CHOICE OF DEVICE SIZE DURING IMPLANTATION. (D11) CONCOMITANT DEVICE(S): BIOLOX DELTA ACETABULAR LINER 36/56-58 - (CAT# 111-22-1010 / SN# (B)(6). ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13 - (CAT# 164-01-13 / SN# (B)(6). FEMORAL HEAD CERAMIC 36M (CAT# 111-152-632 / SN# (B)(6). NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, B6, B7, D4 (EXPIRATION DATE AND UDI NUMBER), D6, AND H4. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO: B5, G4, G3, G7, H1, H2, H3, AND H7. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (D6) IMPLANT DATE CORRECTED.

    Description of Event or Problem · 0

    AS REPORTED THE PATIENT WAS INITIALLY IMPLANTED DURING A LEFT THR ON (B)(6) 2019.THE PATIENT SUFFERED DISLOCATION WHILE HOSPITALIZED FOR THE INITIAL POST OP PERIOD. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE LEFT HIP WAS REVISED ON (B)(6) 2019. THE SURGEON ¿WENT UP 2 SIZES¿ FOR THE STEM WITH HIGH OFFSET AND REPLACED THE FEMORAL HEAD. REPORTEDLY, THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT BEING RETURNED DUE TO FACILITY POLICY.

    Description of Event or Problem · 1

    AS REPORTED THE PATIENT WAS INITIALLY IMPLANTED DURING A LEFT THR ON (B)(6) 2019. THE PATIENT SUFFERED DISLOCATION WHILE HOSPITALIZED FOR THE INITIAL POST OP PERIOD. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE LEFT HIP WAS REVISED. THE SURGEON ¿WENT UP 2 SIZES¿ FOR THE STEM WITH HIGH OFFSET AND REPLACED THE FEMORAL HEAD. REPORTEDLY, THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163781 NOVATION ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12 MEH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention