BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC TIBIAL TRAY

    MDR report key: 20865319 · Received December 6, 2024

    Report

    Report Number
    1038671-2024-04669
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    August 24, 2020
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2023-01814. D10 CONCOMITANTS: 3778382, 02-012-45-1505 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 0.5T; 4036046, 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5; 4082467, 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK; 4206960, 02-012-48-1509 - LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM; 4351283, 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; 4412159, 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5; 4418540, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK; 4424106, 200-02-29 - THREE PEG PATELLA 29MM; 4454699, 200-02-29 - THREE PEG PATELLA 29MM. G4: 510K UNKNOWN DUE TO SPECIFIC DEVICE NOT REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2023-01814. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, INSTABILITY AND METALLOSIS COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    1038671-2023-01814 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-01814. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, METAL WEAR AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL 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 BILATERAL KNEE REPLACEMENT ON (B)(6) 2016. FOLLOWING THE SURGERIES, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, SWELLING, UNSTEADINESS IN BOTH KNEES, AND SIGNIFICANT GAIT IMPAIRMENT. DUE TO THIS WORSENING PAIN AND INSTABILITY CAUSED BY THE ACCELERATED WEAR OF HER IMPLANT, THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2020. DURING HER LEFT KNEE REVISION SURGERY, THE PATIENT'S SURGEON NOTED ¿SOME WEAR OF THE TIBIAL BASEPLATE¿ AND ¿SIGNIFICANT WEAR OF THE TIBIAL INSERT.¿ THE PATIENT'S SURGEON DISCOVERED ¿SIGNIFICANT METALLOSIS IN THE JOINT,¿ ¿DEPOSITION OF METALLOSIS IN THE SOFT TISSUE AND IN THE BONES OF THE KNEE JOINT,¿ AND ¿SIGNIFICANT DESTRUCTION OF SOFT TISSUE AND BONE FROM THE METALLOSIS WHICH WAS PRESENT.¿ THE PATIENT'S SURGEON ALSO NOTED INCREASED ¿COMPLEXITY OF THE CASE¿ DUE TO THE ¿SIGNIFICANT METALLOSIS IN THE JOINT¿ WHICH ¿NECESSITATE[ED] SIGNIFICANT DEBRIDEMENT OF ARTHROFIBROTIC TISSUE WITH METALLOSIS.¿ THE SURGEON DISCOVERED ¿SIGNIFICANT BONE LOSS, ESPECIALLY ON THE FEMORAL SIDE OF THE JOINT.¿ THESE ISSUES RESULTED IN AN ¿EXTENDED TIME NEEDED FOR SURGICAL INTERVENTION WITH SURGERY,¿ WITH THE REVISION SURGERY TAKING ROUGHLY FOUR HOURS TO COMPLETE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093754 OPTETRAK LOGIC TIBIAL TRAY PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R