BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 5, 13MM

    MDR report key: 17334502 · Received July 17, 2023

    Report

    Report Number
    1038671-2023-01679
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    April 15, 2022
    Report Date
    October 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174635
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE UPDATED: 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. HOWEVER, THE REPORTED PROSTHESIS WEAR, INSTABILITY, AND FEMORAL LOOSENING 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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-012-51-4013 - LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM 2855022 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4 2618033 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5 2241853 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T 2965312 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 3691458 200-02-38 - THREE PEG PATELLA 38MM 3602242 200-02-38 - THREE PEG PATELLA 38MM 3602296 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 2950666 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE 3767188 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 3686417 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 3830134 PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE 59 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 7 YEARS AND 2 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: FAILED RIGHT KNEE ARTHROPLASTY DUE TO POLYETHYLENE WEAR AND FLEXION INSTABILITY, FEMORAL COMPONENT FOUND TO BE THE DEBONDED FROM THE CEMENT. "COPIOUS STRAW-COLORED SYNOVIAL FLUID WAS OBTAINED. I THEN SENT SYNOVIAL SPECIMENS FOR CULTURE AS WELL AS FROZEN PATHOLOGY. A GENEROUS MEDIAL PEEL WAS PERFORMED TO ASSIST WITH EXPOSURE. A PARTIAL SYNOVECTOMY WAS PERFORMED TO REESTABLISH THE MEDIAL AND LATERAL GUTTERS. NEXT, THE POLYETHYLENE WAS REMOVED WITH AN OSTEOTOME. THERE WAS NO GROSS EVIDENCE OF POLYETHYLENE WEAR. THE FEMUR WAS THEN EASILY ABLE TO BE DISIMPACTED. THE IMPLANT WAS FOUND TO BE COMPLETELY DE BONDED FROM THE UNDERLYING CEMENT. THERE IS NO CEMENT ATTACHED TO THE FEMORAL COMPONENT. THE REMAINING CEMENT WAS REMOVED PIECEMEAL WITH AN OSTEOTOME, TAKING CARE TO AVOID DAMAGING THE REMAINING BONE STOCK. THE PATIENT WAS ROUSED FROM ANESTHESIA, HAVING TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION. HE WAS BROUGHT TO PACU IN STABLE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628538 LOGIC CR TIB INSERT SLOPE++, SZ 5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. 02-012-49-5013 UNK 10885862174635

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention