BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    MDR report key: 15713549 · Received November 2, 2022

    Report

    Report Number
    1038671-2022-01391
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    March 19, 2019
    Report Date
    July 26, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174444
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR.

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 02-012-47-4009, SERIAL NUMBER: (B)(6). EXPIRATION DATE: 03-JUL-2025, UNIQUE IDENTIFIER (UDI) #:(B)(4). (D10) CONCOMITANT DEVICE(S): 4777508 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4 4874892 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 4972565 200-02-38 - THREE PEG PATELLA 38MM (G4) PMA/510(K)NUMBER: K111400. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AS STATED IN THE LEGAL DOCUMENTATION. HOWEVER, THE ROOT CAUSE OF THE PROSTHESIS CANNOT BE DETERMINED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES, PRE-REVISION RADIOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. (H4) DEVICE MANUFACTURE DATE: 05-JUL-2017. H7 & H9 SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: LOGIC CR TIB INSERT STD, SZ 4, 9MM (H6) COMPONENT CODE: 734, BEARINGS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL, APPROXIMATELY 2 YEARS POST OP THE INITIAL RIGHT TKA IMPLANT, THIS MALE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. FOLLOWING THE REVISION SURGERY, THE PATIENT "EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE." NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274550 LOGIC CR TIB INSERT STD, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862174444

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention