BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 18833663 · Received March 4, 2024

    Report

    Report Number
    1038671-2024-00388
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    January 31, 2024
    Report Date
    December 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173607
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER D10: CONCOMITANTS: 5891788 - 02-010-01-0335 - LGC FEMORAL PS CEM RIGHT SZ 3.5 5968642 - 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T 6191471 - 200-02-35 - THREE PEG PATELLA 35MM 5911557 - 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM 5843892 - 204-70-00 - TIBIAL STEM EXT. SCREW ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H2: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR AND DELAMINATION MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 - INVESTIGATION FINDINGS - 4243 "PACKAGING MATERIALS PROBLEM", AND 3221 "NO FINDINGS AVAILABLE" NO LONGER APPLY. INVESTIGATION CONCLUSION - 22 "KNOWN INHERENT RISK OF DEVICE" CHANGED TO D1501 "CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY".

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR AND DELAMINATION MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. 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 76 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. A SYNOVECTOMY FOUND TRACES OF OSTEOLYSIS DUE TO POLY WEAR. THE POLY LINER AND PATELLA WERE EXCHANGED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE EVENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519502 OPTETRAK LOGIC SEE H10 JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM UNK 10885862173607

    Patients

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