BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM

    MDR report key: 19208815 · Received April 29, 2024

    Report

    Report Number
    1038671-2024-01007
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    April 8, 2024
    Report Date
    November 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173607
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: SERIAL NUMBER: 07 0140 14 004; ITEM NUMBER: A10007 - FULL DESCRIPTION: GPS KNEE IMPLANT KIT. SERIAL NUMBER: 3001497; ITEM NUMBER: 204-32-01 - FULL DESCRIPTION: FLUTED STEM EXTENSION 11L X 12 MM. SERIAL NUMBER: 3629269; ITEM NUMBER: 200-02-35 - FULL DESCRIPTION: THREE PEG PATELLA 35MM. SERIAL NUMBER: 3641146; ITEM NUMBER: 02-010-01-0335 - FULL DESCRIPTION: LOGIC FEMORAL PS CEM RIGHT SZ 3.5. SERIAL NUMBER: 3703858; ITEM NUMBER: 204-70-00 - FULL DESCRIPTION: TIBIAL STEM EXT. SCREW. SERIAL NUMBER: 3723093; ITEM NUMBER: 02-012-45-3535 - FULL DESCRIPTION: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY 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 RIGHT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2014 AND THEN WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, INSTABILITY, BONY DEFECTS, AND DEVICE FAILURE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887126 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.