BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 9279442 · Received November 5, 2019

    Report

    Report Number
    1038671-2019-00562
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 23, 2019
    Report Date
    May 14, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862035110
    PMA / PMN Number
    K080980
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED IN THE REVISION AS REPORTED, A PATIENT EXPERIENCED A REVISION DUE TO PROXIMAL FRACTURE TO RIGHT HIP, DUE TO A FALL. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE FOR THE BONE FRACTURE WAS THE PATIENT CONDITIONS. (D11) CONCOMITANT DEVICE(S): OPTIMUS Q DRILL 40MM (CN: (B)(4),SN: (B)(6). LOGICAL CUP - 3 HOLES, 48MM (CN: (B)(4),SN: (B)(6). BONE SCREW 25MM(CN: (B)(4),SN: (B)(6). BONE SCREW 25MM (CN: (B)(4),SN: (B)(6). FEMORAL HEAD CERAMIC 32M (CN: (B)(4),SN: (B)(6). BIOLOX DELTA ACETABULAR LINER 32/48-50 (CN: (B)(4),SN: (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT EXPERIENCED A REVISION DUE TO PROXIMAL FRACTURE TO RIGHT HIP. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE FOR THE BONE FRACTURE WAS THE PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): OPTIMUS Q DRILL 40MM (CN: 192-072-013, SN: (B)(4)), LOGICAL CUP - 3 HOLES, 48MM (CN: 111-12-3348, SN: (B)(4)), BONE SCREW 25MM (CN: 111-12-9125, SN: (B)(4)), BONE SCREW 25MM (CN: 111-12-9125, SN: (B)(4)), FEMORAL HEAD CERAMIC 32M (CN: 111-152-622, SN: (B)(4)), BIOLOX DELTA ACETABULAR LINER 32/48-50 (CN: 111-22-1005, SN: (B)(4)).

    Description of Event or Problem · 1

    REVISION DUE TO PROXIMAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073121 NOVATION ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13 MEH EXACTECH, INC. 164-01-13 10885862035110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention