BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM

    MDR report key: 17424186 · Received July 31, 2023

    Report

    Report Number
    1038671-2023-01814
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    August 24, 2020
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144379
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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: 1038671-2024-04669. D10: CONCOMITANTS: (B)(6), 02-012-45-1505 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 0.5T, (B)(6), 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5, (B)(6), 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK, (B)(6), 02-012-48-1509 - LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM, (B)(6), 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T, (B)(6), 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5, (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, (B)(6), 200-02-29 - THREE PEG PATELLA 29MM, (B)(6), 200-02-29 - THREE PEG PATELLA 29MM. 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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 02-012-45-1505 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 0.5T. (B)(6) 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5. (B)(6) 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. (B)(6) 02-012-48-1509 - LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM. (B)(6) 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. (B)(6) 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5. (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. (B)(6) 200-02-29 - THREE PEG PATELLA 29MM. (B)(6) 200-02-29 - THREE PEG PATELLA 29MM. PENDING INVESTIGATION.

    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, AND 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
    645426 LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM UNK 10885862144379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H10.| SEE H11.