MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - usa.Patient id: (b)(6).It was reported by the legal department, the patient received a right total knee replacement on (b)(6) 2019 with no complications.On (b)(6) 2022, approximately 3 years 5 months from the initial, the patient received a revised right knee replacement due to ¿the patient had moderate debris synovitis.It was actually not as bad as the previous arthroscopy.The femur and tibia were evaluated and both were intact without any evidence of loosening." an arthroscopy was performed on (b)(6) 2022.There is no device return.There are no photos or other images of the device provided.No additional information is available.510k: k110547.
Additional Manufacturer Narrative
Concomitant medical product(s): 02-010-01-0350 - 4180291 - logic femoral ps cem right sz 5; 02-012-41-5050 - 5108397 - logic tibia traptray cem sz 5f/5t; 200-02-32 - 5661792 - three peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Added information to e3, e4, h7, and h9.Added component code to h6.H6: investigation results - the revision reported was likely the result of polyethylene wear as stated in the operative notes.The extent and root cause of the polyethylene wear cannot be determined as the device was not available for evaluation, and radiographs and photographs were not provided.A contributing factor to the polyethylene wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.H6: corrected clinical code, impact code, and problem code to more accurately reflect the reported event.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: 16701940
• Report Number: 1038671-2023-00614
• Device Sequence Number: 20289031
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 02/20/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• Device Catalogue Number: 02-012-44-5011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 05/11/2026
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 08/18/2023; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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: 67 YR
• Patient Sex: Male