BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 13MM

    MDR report key: 19029839 · Received April 2, 2024

    Report

    Report Number
    1038671-2024-00718
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    October 23, 2014
    Report Date
    November 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001825
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 3709498 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3 2031811 02-012-41-3030 - LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T AA7493 1200-A - CEMEX RX 40G LOW VISCOSITY 3559099 200-02-35 - THREE PEG PATELLA 35MM 3620962 201-78-81 - 3" TROCAR, MOD. HEX 2PK 3730636 201-78-88 - 4" DRILL BIT, MOD. HEX 2-PK 3688501 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 3744151 204-70-00 - TIBIAL STEM EXT. SCREW 5385043 02-022-44-3011 - TRULIANT TIB IMP PSC INSERT SZ 3, 11MM THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND/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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. THE PATIENT HAS NOT BEEN SURGICALLY REVISED. THERE IS NO OTHER PATIENT OR MEDICAL INFORMATION PROVIDED. THERE ARE NO IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PROVIDED/ SEARCHABLE INFORMATION DOES NOT CLARIFY THE LEG IN WHICH THE DEVICE WAS ACTUALLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545600 LOGIC TIBIA PS MOD INSRT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001825

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention SEE H10