BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM

    MDR report key: 17983919 · Received October 23, 2023

    Report

    Report Number
    1038671-2023-02579
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    September 12, 2022
    Report Date
    December 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063977
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0020-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G, H. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND PRODUCT INFORMATION WERE NOT PROVIDED. 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2007. APPROXIMATELY 15 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: RIGHT KNEE OSTEOLYSIS, INSTABILITY, LOOSENING FEMORAL COMPONENT AND POLYETHYLENE WEAR FINDINGS: SYNOVITIS CONSISTENT WITH POLY WEAR AND LOOSENING. NO GROSS EVIDENCE OF INFECTION. GLOBAL INSTABILITY WITH 3 DEG HYPEREXTENSION. DEBONDED LOOSE FEMORAL COMPONENT. SEVERE POLY WEAR WITH DELAMINATION AND FREE FRAGMENTS IN THE TISSUE. SEVERE OSTEOLYSIS FEMUR CENTRALLY WITH INVOLVEMENT OF BOTH CONDYLES WITH SUPPORTIVE DISTAL BONE AND REMAINING POSTERIOR CONDYLE STRUTS TYPE IIB BONE LOSS. OSTEOLYSIS TIBIA IIB. SEVERE OSTEOLYSIS PATELLA WITH INADEQUATE REMAINING BONE TO SUPPORT REVISION RESURFACING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942413 OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862063977

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention UNK.