MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - three peg patella 35mm (cat# 200-02-35 / serial# (b)(6) - logic cr femoral por, right, sz 2.5 (cat# 02-010-04-0325 / serial#(b)(6) - lgc tibial fit tray cem sz 2.5f / 5t (cat# 02-012-45-2525 / serial# (b)(6) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately seven months post right tka revision, the 68 y/o female patient was revised due to osteolysis as well as poly wear and delamination.This poly was in a conforming bag and has only been in since (b)(6) 2023 but it already showed significant damage.The wear characteristics are the same as the other affected poly¿s pitting and wear marks.All components were removed.Patient was not revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation due to they were disposed at hospital.
Additional Manufacturer Narrative
The revision reported was likely the result of osteolysis and presumed prosthesis wear of the tibial insert.However, images of the revised insert do not show signs of excessive prosthesis wear inconsistent with being implanted, and the revised components were not returned for evaluation.
Additional Manufacturer Narrative
D10: (b)(6) 200-02-35 - three peg patella 35mm.This follow-up report is being submitted to relay additional and/or corrected information.The revision reported in case-2023-00011405 was likely the result of osteolysis and presumed prosthesis wear of the tibial insert.However, images of the revised insert do not show signs of excessive prosthesis wear inconsistent with being implanted, and the revised components were not returned to exactech for evaluation.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18477832
• Report Number: 1038671-2024-00052
• Device Sequence Number: 12493483
• Product Code: JWH
• UDI-Device Identifier: 10885862230362
• UDI-Public: 10885862230362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
• Device Catalogue Number: 02-012-51-2509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/01/2024; 06/04/2025
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 80 KG