MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-45-2020
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 02-010-06-0320 femoral component.02-012-44-2015 tibial polyethylene insert.02-012-60-1440 tibial stem extension.02-012-60-1880 stem extension.208-05-02 femoral augment 1 catalog.208-06-02 femoral augment 2 catalog.02-012-66-2000 tibial cone 1.
Event or Problem Description
It was reported via clinical study, that the 61 yo female patient had an wound infection with swelling & discharge from right knee.The wound cultures grew staph haemolyticus, enterococcus faecalis, corynebacterium.(inpatient/prolonged hospitalization).The adverse event date of onset is (b)(6) 2017.The patient was treated with medication.The patient¿s outcome was last known as resolved on (b)(6) 2017.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4, d7a, g4, h6: clinical code, impact code, component code, type of investigation, investigation findings, investigation conclusions based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; no device information was provided.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK LOGIC
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16587769
• Report Number: 1038671-2023-00475
• Device Sequence Number: 5498677
• Product Code: JWH
• UDI-Device Identifier: 10885862003904
• UDI-Public: 10885862003904
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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 Catalogue Number: 02-012-45-2020
• 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: 02/25/2023
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H10.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 77 KG