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

Catalog Number	02-012-35-3015
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	Pain (1994); Muscle/Tendon Damage (4532); Hemarthrosis (4889)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4), category #: a10012 - gps implant kit v2, serial #: (b)(4), category #: 208-06-03 - cc distal fem augment sz 3, 10mm, serial #: (b)(4), category #: 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm, serial #: (b)(4), category #: 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm, serial #: (b)(4), category #: 208-06-03 - cc distal fem augment sz 3, 10mm, serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw, serial #: (b)(4), category #: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, serial #: (b)(4), category #: 02-010-06-0330 - logic cc femoral size 3, right, serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm, serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm, serial #: (b)(4), category #: 02-012-61-2000 - logic offset stem ext coupler 2mm.
Event or Problem Description
It was reported via clinical study, that the 56 yo female patient experienced deep peroneal nerve palsy and acute hemarthrosis causing pain, swelling and toe drop after strenuous therapy.The date of adverse event onset is (b)(6) 2017.The patient was treated with knee aspiration, immobilizer, hold on physical therapy and surgical evacuation of hematoma.The patient¿s outcome was last known as resolved on (b)(6) 2018.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d4 (remove all from initial report - suspect device unknown), g4 (remove 501k from initial report- unknown), h6: clinical codes, impact codes, medical device problem code, component code, type of investigation, investigation findings and investigation conclusion.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 event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition 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: 16605573
• Report Number: 1038671-2023-00500
• Device Sequence Number: 6272501
• Product Code: JWH
• UDI-Device Identifier: 10885862001832
• UDI-Public: 10885862001832
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• 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): 02/09/2026

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: 02-012-35-3015
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 02/09/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female