MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending manufacturer evaluation.Concomitant device(s): 4635290, 02-010-03-0235 - logic cr femoral cem, left, sz 3.5; 3933722, 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t; 4483667, 200-02-32 - three peg patella 32mm.
Event or Problem Description
As reported, approximately 6.5 years post op the initial left tka, this 76 y/o male patient was revised due to complaints of pain, swelling, instability, and dissatisfaction with their left tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision left tka possible poly swap vs full revision.The patient has revision surgery on (b)(6) 2023.The patient underwent a left tka tibial insert poly swap and patella swap.The patient left the or stable.Reported event not related to the breakage of a device and did not lead to surgical delay/prolongation.Product not returning: the implant was sent to the lab and legal at the hospital.Ebi, x-rays and images attached.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported was likely due to the prosthesis wear, the reported instability, or inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.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 3.5, 9 MM
• 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: 16700445
• Report Number: 1038671-2023-00611
• Device Sequence Number: 14870304
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• 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
• Report Date (Section B): 09/17/2025

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: 12/12/2020
• Device Catalogue Number: 02-012-49-3509
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 09/16/2025
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 12/19/2023; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2012
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 111 KG