BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 11MM

    MDR report key: 13417682 · Received February 1, 2022

    Report

    Report Number
    1038671-2022-00113
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 5, 2021
    Report Date
    April 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001931
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE AND PATIENT-RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND PRE-REVISION X-RAYS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. ADDITIONAL INFORMATION: A3, B5, B7, D10. CORRECTED INFORMATION: B2, G, G2, H5, H6. D10: 2110943 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5, 2005826 02-012-41-5050 - LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, D. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOOSENING 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. 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, APPROXIMATELY 8 YEARS AND 10 MONTHS POST RIGHT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 510K-K033883.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, WEAKNESS AND LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447291 LOGIC TIBIA PS MOD INSRT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM UNK 10885862001931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11