MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately seven years post initial right tka, the 75 y/o male patient had a revision due to poly wear.Patient was revised to a crc liner.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images or x-rays.The device is not available for evaluation due to the device was disposed by the hospital.No further information provided.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h2, h3 and h6 have been updated accordingly.The revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.The most probable root cause for the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images 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 CR TIB INSERT SLOPE++, SZ 4, 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: geoff gannon
• MDR Report Key: 18764643
• Report Number: 1038671-2024-00314
• Device Sequence Number: 19948946
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K11140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2025

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 Expiration Date: 09/22/2023
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
• Device Catalogue Number: 02-012-49-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 04/23/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 06/11/2024; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL COMPONENT CR, CEMENTED SIZE.; FIT TIBIAL TRAY CEMENTED SIZE 4F/4.; THREE PEG PATELLA, 35MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male