BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 6 9MM

    MDR report key: 18531240 · Received January 17, 2024

    Report

    Report Number
    1038671-2024-00105
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    November 6, 2023
    Report Date
    March 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001962
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS LGC TIBIAL FIT TRAY CEM SZ 6F / 5T (CAT# 02-012-45-6050 / SERIAL# (B)(6)). LOGIC FEMORAL PS CEM LEFT SZ 6 (CAT# 02-010-01-0260 / SERIAL# (B)(6)). 3" DRILL BIT, MOD. HEX 2 PACK (CAT# 201-78-89 / SERIAL# (B)(6)). THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(6)). THREADED PIN SIZE 2.3 COLLARED 2PK (CAT# 521-78-23 / SERIAL# (B)(6)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING. OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA MEDWATCH (REF# MW5147862), PATIENT HAD KNEE REPLACEMENT DONE THREE YEARS AGO. IN 2023 PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING, PATIENT HAD X-RAY DONE AND THE PHYSICIAN CONFIRMED THAT THE PATIENT WOULD NEED KNEE REPLACEMENT AGAIN DUE TO A RECALL ON THE PRODUCT. PATIENT HAD REVISION SURGERY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852628 LOGIC TIBIA PS MOD INSRT SZ 6 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 6 9MM UNK 10885862001962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention