BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 9MM

    MDR report key: 21394581 · Received February 18, 2025

    Report

    Report Number
    1038671-2025-00936
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173430
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROSTHESIS WEAR ALLEGED CANNOT BE CONFIRMED AS THE DEVICES HAVE NOT BEEN REVISED. THE REASON FOR THE LEGAL FILING MAY HAVE BEEN DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS COULD NOT BE ASSESSED AS THE DEVICES REMAIN IMPLANTED AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. B3: CORRECTED. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 02-010-01-0215 - LOGIC FEMORAL PS CEM LEFT SZ 1.5, (B)(6), 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T, (B)(6), 200-02-32 - THREE PEG PATELLA 32MM, (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6), 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE, (B)(6), 201-78-88 - 4" DRILL BIT, MOD. HEX 2-PK, (B)(6), 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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

    LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4), PATIENT ID: (B)(6) + LEFT KNEE, (B)(4) RH IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461023 LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11