BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17425035 · Received July 31, 2023

    Report

    Report Number
    1038671-2023-01815
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    November 14, 2022
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144379
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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) 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. (B)(6) 02-012-48-1509 - LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM. (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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, H6 THE FOLLOWING SECTIONS WERE CORRECTED: H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, G.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL ON (B)(6) 2016. FOLLOWING THE SURGERIES, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, SWELLING, AND UNSTEADINESS IN BOTH KNEES, AND SIGNIFICANT GAIT IMPAIRMENT. THE PATIENT CONTINUED TO HAVE PAIN, SWELLING, AND DISCOMFORT IN HER RIGHT KNEE. X-RAYS WERE ¿SUGGESTIVE OF POSSIBLE WEAR OF POLYETHYLENE OF THE KNEE.¿ ON (B)(6) 2022 THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY. THE SURGEON¿S OPERATIVE FINDINGS INCLUDED ¿SOME ARTHROFIBROSIS OF [PATIENT'S] RIGHT TOTAL KNEE ARTHROPLASTY¿ AND ¿WEAR NOTED ON THE POLYETHYLENE OF THE RIGHT TOTAL KNEE ARTHROPLASTY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621831 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 SEE H10.