MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-49-2511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on an unknown date.The patient returned to the surgeon's office with complaints of pain, swelling, instability and dissatisfaction with their left tka.The patient has a recalled implant.Upon examination the patient was scheduled for have a revision tka possible poly swap vs.A complete revision.The patient was revised on (b)(6) 2023.The patient underwent a full knee revision and was revised with a different company's knee system.
Additional Manufacturer Narrative
Pending investigation: d10: 2146575 02-010-03-0225 optetrak logic femoral cr size 2.5 left.3876045 200-02-39 optetrak 3 peg patella cemented 29mm.3824948 02-012-45-2525 optetrak logic fit tray cemented size 2.5f/2.5t.H7: z-0021-2022.
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 over the course of over 8 years of implantation.Additional reasons for the prosthesis wear may be instability, high contact stress during knee flexion, excessive posterior slope, and inclusion of the polyethylene in the packaging recall.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.However, the reported instability and the contributing factors or the sequence of events could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs 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.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 11 MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17177518
• Report Number: 1038671-2023-01430
• Device Sequence Number: 17755485
• Product Code: JWH
• UDI-Device Identifier: 10885862159229
• UDI-Public: 10885862159229
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2019
• Device Model Number: 02-012-49-2511
• Device Catalogue Number: 02-012-49-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2011
• 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: Required Intervention
• Patient Sex: Unknown