BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 8633436 · Received May 22, 2019

    Report

    Report Number
    1038671-2019-00287
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 23, 2019
    Report Date
    August 14, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K032606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H11: (G4) AWARENESS DATE THAT THE ENGINEERING EVALUATION WAS (B)(6) 2019

    Additional Manufacturer Narrative · 0

    H10: (H3) THE ENGINEERING EVALUATION NOTED IN THE REVISION REPORTED IN (B)(4) WAS LIKELY THE RESULT OF INFECTION. THE EVENT AS REPORTED DOES NOT APPEAR TO BE RELATED TO THE DESIGN, MANUFACTURING, OR REASONABLY FORESEEABLE MISUSE OF THE DEVICES. THE INDEX SURGERY OCCURRED IN 2007. ANY ¿SURGICAL SITE¿ INFECTION NOTED IN A PATIENT THAT IS GREATER THAN 3 MONTHS POSTOP FROM A TOTAL JOINT SURGICAL PROCEDURE IS HIGHLY UNLIKELY TO BE RELATED TO THE SURGICAL PROCEDURE FOR PLACEMENT OF THE TOTAL JOINT OR THE DEVICE ITSELF [1]. THEREFORE, THE DHRS AND THE STERILIZATION RECORDS WILL NOT BE REVIEWED. 1. ACUTE INFECTION IN TOTAL KNEE ARTHROPLASTY: DIAGNOSIS AND TREATMENT JUAN CARLOS MARTÍNEZ-PASTOR, FRANCISCO MACULÉ-BENEYTO, AND SANTIAGO SUSO-VERGARA AUTHOR INFORMATION ARTICLE NOTES COPYRIGHT AND LICENSE INFORMATION DISCLAIMER OPEN ORTHOP J. 2013; 7: 197¿204. PUBLISHED ONLINE 2013 JUN 14. SUPERFICIAL AND DEEP INFECTION ARE LISTED UNDER GENERAL SURGICAL RISKS IN THE IFU (700-096-004). (D11) CONCOMITANT DEVICES: 1. CN: 200-04-44, SN: (B)(6) - CEMENTED FINNED TIBIAL TRAY, SIZE 4F/4T. 2. CN: 230-02-04, SN: (B)(6) - OPTETRAK ASYMETRIC, CR CEMENTED FEMORAL, SIZE 4.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICES: (B)(4), SN: (B)(4) - CEMENTED FINNED TIBIAL TRAY, SIZE 4F/4T. (B)(4): 230-02-04, SN: (B)(4) - OPTETRAK ASYMETRIC, CR CEMENTED FEMORAL, SIZE 4.

    Description of Event or Problem · 1

    DR. (B)(6) REVISED A KNEE THAT HAD BECOME INFECTED. PATIENT WAS STABLE AS THEY LEFT THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424755 OPTETRAK OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4, JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SEE. H10.