BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    MDR report key: 15292813 · Received August 25, 2022

    Report

    Report Number
    1038671-2022-00964
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    July 26, 2022
    Report Date
    April 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862064042
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: NO DEVICE RETURN ANTICIPATED AS THE PATIENT REQUESTED THE DEVICES. CONCOMITANTS: 02-012-45-4030 LGC TIBIAL FIT TRAY CEM SZ 4F / 3T K101981. RECALL: Z-2112 THRU 2133-2021. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, THE PROSTHESIS WEAR MAY HAVE BEEN THE RESULT OF EXCESSIVE POSTERIOR SLOPE OF THE TIBIAL TRAY, MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES. AN ADDITIONAL CONTRIBUTING FACTOR TO THE TIBIAL INSERT DAMAGE MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE ASEPTIC (NON-INFECTED) TIBIAL LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE TIBIAL TRAY AND THE BONE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, WHO HAD THEIR RIGHT KNEE INITIALLY IMPLANTED ON (B)(6) 2014, WAS BROUGHT BACK FOR RIGHT KNEE PAIN APPROXIMATELY 7 YEARS 10 MONTHS THE INITIAL IMPLANT PROCEDURE. THE POLY WAS REMOVED WITH SIGNIFICANT WEAR. THE TIBIA WAS FOUND TO BE LOOSE AND REMOVED AS WELL. THE PATIENT RECEIVED A TRULIANT 4/3 TIBIAL TRAY, 13MM STEM, A STEM EXTENSION SCREW, AND A NEW SIZE 15MM PS HIGH FLEX INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNING AS THE PATIENT HAS REQUESTED THE IMPLANTS.

    Description of Event or Problem · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH PROSTHESIS WEAR AND TIBIAL LOOSENING. THE PROSTHESIS WEAR MAY HAVE BEEN THE RESULT OF EXCESSIVE POSTERIOR SLOPE OF THE TIBIAL TRAY, MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES. AN ADDITIONAL CONTRIBUTING FACTOR TO THE TIBIAL INSERT DAMAGE MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE ASEPTIC (NON-INFECTED) TIBIAL LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE TIBIAL TRAY AND THE BONE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146943 OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM UNK 10885862064042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H