MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
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); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.
Event or Problem Description
As reported, the patient had an initial right tka on an unknown date.The patient returned to the surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient had a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs.A full revision.The patient was revised on (b)(6) 2023 and the tibial poly implant was swapped.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
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.However, the reported instability could not be confirmed from the provided information.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and were not provided.D4: corrected.D10: concomitant devices: (b)(6), 02-010-03-0340 - logic cr femoral cem, right, sz 4; (b)(6), 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t; (b)(6), 200-05-26 - inset patella 26mm.G4: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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.However, the reported instability could not be confirmed from the provided information.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 TIB INSERT IMPL CRC, SZ 4, 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18263948
• Report Number: 1038671-2023-02904
• Device Sequence Number: 14426506
• Product Code: JWH
• UDI-Device Identifier: 10885862230485
• UDI-Public: 10885862230485
• 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: 2013
• 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): 03/05/2025

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: 01/15/2018
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
• Device Catalogue Number: 02-012-51-4009
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 02/20/2025; 03/04/2025
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/20/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 121 KG