MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2011
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	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): logic cf femur sz 2 cemented; 02-012-45-2030, logic tibia cemented fit tray 2f/3t; 200-02-26, patella 3 peg round 26mm; 02-012-49-2011, poly insert cr slope ++ sz1 11mm.
Event or Problem Description
As reported, approximately 7 years post op the initial right tka, this 73 y/o female patient was revised due to complaints of pain, swelling, instability, and dissatisfaction.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6) 2023.The patient underwent a right tka tibial poly swap and patella implant swap.The patient left the or stable following full revision.Devices are not returning, the implant is required to go to the lab and legal at the hospital.
Additional Manufacturer Narrative
Section h10: (h3) the logic device information is not provided.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Section h10: (g2) report source - company representative should have been checked (g4) date received by manufacturer ¿ date on final submission should have been (b)(6) 2023 (g6) type of report - 30-day should have been checked along with follow-up.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion and h11 the reported event was likely the result of prosthesis wear of their tibial insert and patellar components.Another contributing factor to the revision may include instability, as reported; however, this instability could not be confirmed.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, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16763686
• Report Number: 1038671-2023-00730
• Device Sequence Number: 19598418
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• 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 Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/22/2026

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 Catalogue Number: 02-012-49-2011
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 01/12/2024; 04/02/2026
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/12/2024; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 97 KG