BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 8457206 · Received March 27, 2019

    Report

    Report Number
    1038671-2019-00200
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 18, 2019
    Report Date
    August 26, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED IN THE EXPERIENCE WAS LIKELY THE RESULT OF "PAIN AND SOME MID-FLEXION INSTABILITY." HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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] THE INDEX SURGERY OCCURRED IN 2008, INDICATING THE THAT THESE DEVICES HAVE BEEN IMPLANTED FOR APPROXIMATELY 11 YEARS. THEREFORE, NEITHER THE DHR NOR THE STERILIZATION RECORDS WERE 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. INTRACTABLE PAIN IS LISTED IN THE TOTAL JOINT SURGERY RISKS SECTION OF THE OPTETRAK LOGIC TOTAL KNEE SYSTEM IFU 700-096-119 REV A. ADDITIONALLY, POSSIBLE CAUSES OF INSTABILITY FOR THESE DEVICES ARE LISTED IN RMR # 750-2010-016 RMR-IMPLANTS REV - AND RMR # 750-1992-001-RMR-IMPLANTS REV A.

    Additional Manufacturer Narrative · 0

    SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN (B)(6) 2019. (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR.

    Additional Manufacturer Narrative · 0

    H11: CORRECTION: THE AWARE DATE SUBMITTED ON SUPPLEMENTAL REPORT 1038671-2019-00200 FOLLOW UP 2 WAS INCORRECT. THE AWARE DATE SHOULD BE (B)(6) 2019.

    Description of Event or Problem · 0

    REVISION KNEE SURGERY FOR ANTERIOR KNEE PAIN AND SOME MILD MID-FLEXION INSTABILITY. THE PATIENT HAD AN ORIGINAL OPTETRAK CR PERFORMED BY DR. (B)(6) IN 2008. THE PATIENT RECEIVED A RESURFACED OPTETRAK 38MM 3 PEG PATELLA AND A SIZE 3 13MM CRC INSERT. THE RETRIEVED POLY WAS IN EXCELLENT CONDITION FOR ITS AGE SHOWING MINIMAL WEAR ON THE ARTICULAR SURFACE AND BACK SIDE OF THE POLY. THIS EVENT HAS 2 DEVICES 1038671-2019-00200 AND 1038671-2019-00201.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    REVISION KNEE SURGERY FOR ANTERIOR KNEE PAIN AND SOME MILD MID-FLEXION INSTABILITY. THE PATIENT HAD AN ORIGINAL OPTETRAK CR PERFORMED BY DR. (B)(6) IN 2008. THE PATIENT RECEIVED A RESURFACED OPTETRAK 38MM 3 PEG PATELLA AND A SIZE 3 13MM CRC INSERT. THE RETRIEVED POLY WAS IN EXCELLENT CONDITION FOR ITS AGE SHOWING MINIMAL WEAR ON THE ARTICULAR SURFACE AND BACK SIDE OF THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251090 OPTETRAK LOGIC TIB INSERT IMPL CRC, SZ 3, 13MM JWH EXACTECH, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention