BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    MDR report key: 20008433 · Received August 20, 2024

    Report

    Report Number
    1038671-2024-02898
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    September 14, 2023
    Report Date
    July 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001764
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. ADDITIONAL INFORMATION: B5, G2, G3, H10 CORRECTED: H6 CLINICAL CODES.

    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 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 RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED. H6: CORRECTED HEALTH EFFECT CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3809396 02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5 3958140 204-70-00 - TIBIAL STEM EXT. SCREW 3958587 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T 3981224 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 3944817 200-02-32 - THREE PEG PATELLA 32MM 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 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 REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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 RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED WAS MOST LIKELY DUE TO TIBIAL INSERT PROSTHESIS WEAR. THE ALLEGED FEMORAL LOOSENING CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE OCCURRED AS A RESULT OF PROSTHESIS WEAR 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. H6: CORRECTED HEALTH EFFECT CLINICAL CODES. H10: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 100 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING. A REVISION OP REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED PREMATURE WEAR OF THE POLYETHYLENE LINER AND ASEPTIC LOOSENING OF LEFT TOTAL KNEE ARTHROPLASTY FEMORAL COMPONENT. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT WEAR TO THE LINER AND A LOOSE FEMORAL COMPONENT. IT WAS NOTED THE PATELLAR AND TIBIAL COMPONENTS WERE WELL FIXED WITHOUT ANY SIGNS OF SIGNIFICANT OSTEOLYSIS OR LOOSENING SURROUNDING THE IMPLANTS. THE LINER AND FEMORAL COMPONENTS WERE REVISED. NO MEDICAL OR SURGICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 100 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044827 LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001764

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention| H SEE H11.