BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 15MM

    MDR report key: 19103384 · Received April 15, 2024

    Report

    Report Number
    1038671-2024-00829
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    August 22, 2023
    Report Date
    October 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174475
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10. H10. PENDING INVESTIGATION. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. CONCOMITANT PRODUCTS: 4123569 - 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4. 4185888 - 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 2937776 - 200-02-38 - THREE PEG PATELLA 38MM. 2885446 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 2640058 - 201-78-80 - 3" TROCAR, HEX 2PK. 2899877 - 201-78-81 - 3" TROCAR, MOD. HEX 2PK. 46331 - 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED. MANUFACTURER NARRATIVE: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE PROSTHESIS WEAR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470662 LOGIC CR TIB INSERT STD, SZ 4, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention