BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM

    MDR report key: 20347464 · Received October 1, 2024

    Report

    Report Number
    1038671-2024-03778
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    September 30, 2024
    Report Date
    May 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174529
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES (B)(6) 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; (B)(6) 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T; (B)(6) 200-02-38 - THREE PEG PATELLA 38MM. 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 CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1. B3: DATE OF EVENT UNKNOWN B5. H6: HEALTH EFFECT IMPACT CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE 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 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

    LEGAL CASE ¿ USA. PATIENT ID: (B)(6) + RIGHT KNEE. RE: EMPLOYEE: (B)(6). EMPLOYER: (B)(6). DATE OF INJURY:(B)(6) 2010. CLAIM NUMBER: (B)(6). TO WHOM IT MAY CONCERN, I AM WRITING TO YOU REGARDING THE ABOVE EMPLOYEE¿S WORKER¿S COMPENSATION CLAIM. MR. MOORE WAS INJURED WHILE WORKING FOR VIRGINIA PUBLIC UTILITIES WHICH REQUIRED RIGHT KNEE SURGERY. THE POLYETHYLENE LINER USED WAS RECALLED BY YOUR COMPANY. THIS REQUIRED MR. MOORE TO HAVE A SECOND SURGERY DUE TO THE RECALL. I HAVE ATTACHED THE SERIAL NUMBERS/INFORMATION RELATED TO THE RECALL. GIVEN THE RECALL, REPEAT SURGERY WAS REQUIRED IN WHICH MEDICAL TREATMENT AND INDEMNITY BENEFITS WERE PAID UNDER MN WORKER¿S COMPENSATION. THE LEAGUE OF MN CITIES INSURANCE TRUST HAVE MADE THE FOLLOWING PAYMENTS UNDER MN WORKER¿S COMPENSATION STATUE: MEDICAL: (B)(6). INDEMNITY: (B)(6). PLEASE CALL ME AT (B)(6) TO DISCUSS OUR CLAIM OR SUBMIT YOUR CHECK IN THE AMOUNT OF $29,429.55, PAYABLE TO THE LEAGUE OF MINNESOTA INSURANCE TRUST AND MAIL IT TO THE ADDRESS BELOW. PLEASE FEEL FREE TO CONTACT ME WITH ANY QUESTIONS. SINCERELY, (B)(6). THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-49-4011 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM. SERIAL: (B)(6). 510K: K111400. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6) 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4. (B)(6) 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T. (B)(6) 200-02-38 - THREE PEG PATELLA 38MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND WAS REVISED ON AN UNKNOWN DATE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45195 LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174529

    Patients

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