MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 3.5, 13MM
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); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5.5 years post initial left tka, the 76 y/o male patient had an original exactech tka done.The patient returned to surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled poly implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient underwent a poly insert and patella implant swap.Patient was revised to truliant crc tibial insert sz 3.5, 17mm and an optetrak 3 peg patella.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due to the implant(s) is sent to the lab and legal at the hospital.Images, x-rays, ebi attached.No further medical/patient information provided.
Additional Manufacturer Narrative
Section d10: concomitant products: patella 3 peg 32mm (cat# 200-02-32 / serial# (b)(6)).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: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported was likely due to the reported instability and prosthesis wear, or inclusion of the tibial insert in the packaging recall.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Prosthesis wear of the patella implant could not be confirmed from the provided information.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 TIB INSERT IMPL CRC, SZ 3.5, 13MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18763457
• Report Number: 1038671-2024-00309
• Device Sequence Number: 4387248
• Product Code: JWH
• UDI-Device Identifier: 10885862230461
• UDI-Public: 10885862230461
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 09/08/2025

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: 02/27/2022
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 3.5, 13MM
• Device Catalogue Number: 02-012-51-3513
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 09/06/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T.; LOGIC CR FEMORAL CEM, LEFT, SZ 3.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG