BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    MDR report key: 19989968 · Received August 15, 2024

    Report

    Report Number
    1038671-2024-02850
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    August 14, 2024
    Report Date
    April 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173638
    PMA / PMN Number
    K110547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES 4060251 02-012-42-4008 - LOGIC PTS, SIZE 4, 8MM 5037783 200-02-41 - THREE PEG PATELLA 41MM 5173823 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4 5245623 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T 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 DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR, INSTABILITY, AND FEMORAL 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CONSCIOUS PAIN AND SUFFERING, OSTEOLYSIS, ADVERSE REACTION, SWELLING, INSTABILITY, BONE LOSS, BONE RESORPTION, TISSUE DESTRUCTION, POLYEHTYLENE WEAR, DEBRIS, COMPONENT LOOSENING, ACCELERATED POLYETHYLENE WEAR, SERIOUS COMPLICATIONS, IMPAIRED MOBILITY, DEBILITATION, PHYSICAL DISABILITY, DISABILITIES OF ACTIVITIES OF DAILY LIFE, MEDICAL BILLS AND EXPENSES, MENTAL ANGUISH, PSYCHOLOGICAL AND EMOTIONAL DISTRESS, FEAR, LOSS OF THE ENJOYMENT OF LIFE, PECUNIARY LOSSES, LOSS OF WAGES, THE ANTICIPATED NEED TO UNDERGO UNNECESSARY AND TRAUMATIC REVISION SURGERY, AND OTHER MEDICAL CONDITIONS . POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094299 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11.