BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM

    MDR report key: 18498602 · Received January 11, 2024

    Report

    Report Number
    1038671-2024-00084
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    January 21, 2021
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174581
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3: THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY BE DUE TO A COMBINATION OF INSTABILITY AND/OR PATIENT CONDITIONS LEADING TO FLUID ACCUMULATION IN THE JOINT SPACE. ADDITIONAL INFORMATION REGARDING THE REVISION WAS PROVIDED AT A LATER TIME DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL; HOWEVER, IT DOES NOT APPEAR THAT THE REASON FOR REVISION WAS RELATED TO PROSTHESIS WEAR. HOWEVER, THE REPORTED FAILURE COULD NOT BE CONFIRMED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. CORRECTION: H6: HEALTH EFFECT CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 3866284 - 02-010-04-0350 - LOGIC CR FEMORAL POR, RIGHT, SZ 5 4118295 - 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 4375898 - 200-02-38 - THREE PEG PATELLA 38MM 4546162 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 4069058 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK 4050653 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 4050680 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 4492160 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 1003016045 A10012 - GPS IMPLANT KIT V2 9027016037 A10012 - GPS IMPLANT KIT V2

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B4. CORRECTION: H6 CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED 5.5 YEAR POST INITIAL RIGHT TKA, THIS 64 Y/O MALE PATIENT WAS REVISED. KNEE WAS LEAKING FLUID OUTSIDE CAPSULE, POSSIBLY DUE TO POLY WEAR CAUSING IT BUT SURGEON WAS NOT SURE AFTER TAKING LINER OUT UNCERTAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING: DISPOSED BY HOSPITAL.

    Description of Event or Problem · 0

    THE PATIENT HAS HAD A PREVIOUS TOTAL KNEE REPLACEMENT WITH A LARGE PRETIBIAL BURSA AS WELL AS A LYMPHOCELE EXTENDING DOWN TOWARDS HIS ANKLE. UNDER A SPINAL AND GENERAL ANESTHETIC THE PATIENT WAS PREPARED ON THE OPERATING TABLE. THE PREVIOUS INCISION WAS UTILIZED TO DISSECT DOWN TO THE EXTRACAPSULAR TISSUES WITH A LARGE PREPATELLAR BURSA BUT ALSO A LYMPHOCELE EXTENDING FROM THE POSTEROMEDIAL ASPECT OF THE KNEE TO APPROXIMATELY 10 CM ABOVE THE ANKLE JOINT. FLUID AND THE LINING OF THE LYMPHOCELE WERE SENT FOR MICROSCOPY, CULTURE AND SENSITIVITY AS WELL AS HISTOPATHOLOGY. THE LYMPHOCELE WAS DRAINED AND THE WALL EXCISED AROUND THE LEVEL OF THE KNEE AND THE DISTAL EXTENSION CURETTED AND DEBRIDED WITHOUT EXTENDING THE INCISION DISTALLY. A MEDIAL PARAPATELLAR ARTHROTOMY WAS PERFORMED TO REVEAL MARKED SYNOVITIS OF THE KNEE JOINT WITH SOME SLIGHT FLEXION AND STABILITY. EXTENSIVE SYNOVECTOMY WAS PERFORMED AND THE 9 MM INSERT WAS EXCHANGED TO AN 11 MM CRC INSERT TO ENSURE STABILITY AND GOOD RANGE OF MOTION. THE KNEE WAS IRRIGATED WITH PULSATILE SALINE LAVAGE ALTERNATING WITH BETADINE PRIOR TO INFILTRATING WITH LOCAL ANAESTHETIC, COLLATAMP G AND SURGICEL POWDER FOR ADDITIONAL HAEMOSTASIS. A 10 MM BELLOVAC DRAIN WAS INSERTED INTO THE LYMPHOCELE AND THE DRAIN BROUGHT OUT THROUGH THE SUPEROMEDIAL ASPECT OF THE KNEE. THE KNEE CAPSULE AND THE REMAINDER OF LAYERS WERE CLOSED WITH THE USE OF STAPLES AND A NEGATIVE PRESSURE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706842 LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862174581

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male SEE H10.