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

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	Unspecified Infection (1930); Unspecified Musculoskeletal problem (4535)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 02-010-06-0210 - logic cc femoral size 1, left.02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t.02-012-61-2000 - logic offset stem ext coupler 2mm.200-02-29 - three peg patella 29mm.02-012-61-6000 - logic offset stem ext coupler 6mm.208-06-01 - cc distal fem augment sz 1, 10mm.
Event or Problem Description
It was reported via clinical study, that the 77 yo female patient experienced stiffness of the left knee.The date of onset is (b)(6) 2018.The patient underwent revision surgery due to infection.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the patient¿s pain 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, g4, h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The reported stiffness cannot be conclusively determined; however, it may be due to patient factors/etiology, component positioning, arthrofibrosis, infection and/or implant selection.This cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
Upon receipt of additional information pertaining to this event, it was determined that the event involved non-exactech devices.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this event should have remained reportable.Please disregard the prior report (1038671-2023-00431-2).

• 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: 16538514
• Report Number: 1038671-2023-00431
• Device Sequence Number: 6452900
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/06/2026

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
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 11/25/2025; 12/04/2025; 01/05/2026
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 09/28/2023; 12/04/2025; 12/04/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG