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

Catalog Number	02-012-65-2011
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 73 yo female patient experienced patellar tendinitis of the right knee, especially when going up and down the stairs (anterior knee pain).The date of adverse event onset is (b)(6) 2017.The patient was treated with exercise modification and prp injection.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
Concomitant medical products : concomitants: serial #: (b)(4) , category #: 02-010-06-0320 - logic cc femoral size 2, right, serial #: (b)(4) , category #: 02-012-50-2011 - logic fit/rbk augment 1/2 block sz 2, 5mm, serial #: (b)(4) , category #: 02-012-50-2011 - logic fit/rbk augment 1/2 block sz 2, 5mm, serial #: (b)(4) , category #: 208-06-02 - cc distal fem augment sz 2, 10mm, serial #: (b)(4) , category #: 208-06-02 - cc distal fem augment sz 2, 10mm, serial #: (b)(4) , category #: 02-012-60-1480 - logic stem ext 14mm x 80mm, serial #: (b)(4) , category #: 02-012-60-1440 - logic stem ext 14mm x 40mm, serial #: (b)(4) , category #: 02-012-61-4000 - logic offset stem ext coupler 4mm, serial #: (b)(4) , category #: 02-012-66-2000 - metaphyseal tibial cone, ml32mm, serial #: (b)(4) , category #: 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event involved a device that is not marketed in the united states, nor has a similar marketed device in the united states.As a result, this complaint event is no longer considered reportable to the fda and this report may be disregarded.

• 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: 16602828
• Report Number: 1038671-2023-00496
• Device Sequence Number: 7325381
• Product Code: JWH
• UDI-Device Identifier: 10885862265876
• UDI-Public: 10885862265876
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• 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: Health Professional,Company Representative
• 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 Expiration Date: 09/17/2023
• Device Catalogue Number: 02-012-65-2011
• 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: 02/06/2026
• 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
• Date Device Manufactured: 09/18/2015
• 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: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 64 KG