BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 15789374 · Received November 14, 2022

    Report

    Report Number
    1038671-2022-01457
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    December 18, 2018
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001894
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A CLINICAL STUDY. CONCOMITANT MEDICAL PRODUCTS: 1960554, 204-34-02, FLUTED STEM EXTENSION 25L X 14 MM; 1969896, 02-012-45-4040, LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; 1985369, 02-010-01-0240, LOGIC FEMORAL PS CEM LEFT SZ 4; 2006178, 200-02-38, THREE PEG PATELLA 38MM; 2012720, 204-70-00, TIBIAL STEM EXT. SCREW. 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 AND INSTABILITY CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITIONS.

    Additional Manufacturer Narrative · 0

    H6 - CLINICAL CODE - IMPLANT PAIN CORRECTED TO PAIN, MEDICAL DEVICE PROBLEM CODE.

    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 INSTABILITY 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. H6: CORRECTED MEDICAL DEVICE AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE EXACTECH KNEE REPLACEMENT STUDY, THAT A 50 YO OVERWEIGHT MALE, INITIALLY HAD A LEFT KNEE IMPLANTED ON (B)(6) 2011, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018, APPROXIMATELY 7 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS COMPLAINING OF PROGRESSIVE PAIN/SWELLING, INSTABILITY WAS REPORTED WITH A DATE OF ONSET, (B)(6) 2018. THERE WAS REVISION OF THE FEMORAL AND TIBIAL INSERT COMPONENTS. THE STUDY INDICATES THE EVENT WAS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. OUTCOME INDICATES RESOLVED. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFF ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375675 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 11MM UNK 10885862001894

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention