MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 3.5, 13 MM; SEE H10

Model Number	LOGIC CR TIB INSERT SLOPE +, SZ 3.5, 13 MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: (b)(4); 02-010-03-0235 - logic cr femoral cem, left, sz 3.5; (b)(4); 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t; (b)(4); 200-02-35 - three peg patella 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 71 yo male patient, initial left total knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2023, approximately 5 years 5 months post the initial procedure.The patient presented with complaints on their left primary knee, including pain and dissatisfaction.It was determined the implanted poly was part of the recall.The patient underwent a poly swap and patella swap.The patient was revised to a size 13mm crc poly for sz 3.5 and a 35mm round 3 peg cemented patella.There were no surgical delays reported.The patient was last known to be in stable condition following the event.The device was returned for analysis.
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 revision reported was likely the result of tibial insert prosthesis wear, the reported instability, or inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall that was packaged for longer than 5 years, or any combination of these possibilities.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, 13 MM
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16668503
• Report Number: 1038671-2023-00572
• Device Sequence Number: 17635461
• Product Code: JWH
• UDI-Device Identifier: 10885862159304
• UDI-Public: 10885862159304
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• 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): 08/13/2025

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: 02/28/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE +, SZ 3.5, 13 MM
• Device Catalogue Number: 02-012-48-3513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2012
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 101 KG