BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM

    MDR report key: 15545271 · Received October 5, 2022

    Report

    Report Number
    1038671-2022-01245
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 10, 2015
    Report Date
    December 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173560
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 3907741 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3, 3804265 02-012-35-4009 - LOGIC TIBIA PS MOD INSRT SZ 4 9MM, 4013163 02-012-41-3030 - LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T, 3946098 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T, 4059977 200-02-35 - THREE PEG PATELLA 35MM, 4060100 200-02-35 - THREE PEG PATELLA 35MM, RECALL (IF RECALL NUMBER IS GIVEN) OR CORRECTION/REMOVAL NUMBER: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    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 PENDING REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR.

    Additional Manufacturer Narrative · 0

    RELATED: MFR#1038671-2024-02532 REPORT 2 OF 2. H11. ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION ADDED. REPORT 1 OF 2. PENDING UPDATED INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR, INSTABILITY, AND/OR 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. 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, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015. IN LATE 2019 THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING, AND INSTABILITY IN HER LEFT KNEE. AN MRI PERFORMED ON (B)(6) 2022 DEMONSTRATED "DEBRIS-CONTAINING SYNOVIAL EXPANSION IS NOTED CONSISTENT WIT POLYMERIC WEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467237 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-44-3011 10885862173560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H10.