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)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Synovitis (2094); Joint Laxity (4526); Muscle/Tendon Damage (4532); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a 73 yo male patient, initial left knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 9 months post the initial procedure.The patient presented with complaints of pain, swelling, instability, and dissatisfaction with their tka.Upon examination, the patient was scheduled for a revision tka, possible poly swap.During the procedure, the poly and patella implants were swapped.Revised to a truliant crc tibial insert sz 3.5, 15mm sn: (b)(6) and an optetrak 3 peg patella 32mm sn: (b)(6).There were no device breakages or surgical delays during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.No device returns for analysis anticipated.The devices were sent to the lab and legal at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 2865247 - 02-010-03-0235 - logic cr femoral cem, left, sz 3.5; 4159790 - 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t; 5491911 - 200-02-32 - three peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be instability and inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene wear include high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The reported instability 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 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 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18655498
• Report Number: 1038671-2024-00169
• Device Sequence Number: 7084292
• Product Code: JWH
• UDI-Device Identifier: 10885862159335
• UDI-Public: 10885862159335
• 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: 2019
• Device Explanted Year: 2024
• 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): 08/11/2025

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: 04/29/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM
• Device Catalogue Number: 02-012-49-3513
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG