BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 11MM

    MDR report key: 17119722 · Received June 13, 2023

    Report

    Report Number
    1038671-2023-01331
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    September 4, 2020
    Report Date
    December 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS- -THERE IS NO SPECIFIC OPTETRAK LOGIC DEVICE INFORMATION PROVIDED. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5, (B)(6), 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, (B)(6), 13A2101 - CEMEX SYSTEM FAST GENTA 70G, (B)(6), 200-02-35 - THREE PEG PATELLA 35MM, (B)(6), 201-78-81 - 3" TROCAR, MOD. HEX 2PK, (B)(6), 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK, (B)(6), 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19, (B)(6), THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: CONCOMITANT DEVICES: 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5, (B)(6), 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, (B)(6), 13A2101 - CEMEX SYSTEM FAST GENTA 70G, (B)(6), 200-02-35 - THREE PEG PATELLA 35MM, (B)(6), 201-78-81 - 3" TROCAR, MOD. HEX 2PK, (B)(6), 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK, (B)(6), 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19, (B)(6), H6 (COMPONENT CODE, TYPE OF INVESTIGATION). THE FOLLOWING SECTIONS WERE CORRECTED: H6 (HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE). 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. 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 AND RADIOGRAPHS 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, THIS PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6)2018. THEY HAD RIGHT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 2 YEARS 7 MONTHS AFTER THEIR INITIAL IMPLANTATION. PATIENT CLAIMS TO HAVE HAD THE FOLLOWING SYMPTOMS: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, LOOSENING, INSTABILITY, POLYETHYLENE WEAR, OSTEOLYSIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. 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
    2215184 LOGIC CR TIB INSERT STD, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNK

    Patients

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