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

Catalog Number	02-012-35-2013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 02-010-01-0220 - logic femoral ps cem left sz 2.02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(h3) pending evaluation.
Event or Problem Description
As reported by the exactech knee replacement study, the 74-year-old patient had a left tka on (b)(6) 2014.The patient presented with inflammation / pain on unk-unk-2016.It was further stated - soft tissue retinaculum inflammation gradual onset approx.2016.Left knee - lateral aspect pain.The action taken is other - reviewed on (b)(6) 2024.Now resolved.The outcome of this event is considered resolved on (b)(6) 2024.The case report form indicates that this event is definitely not related to the device and possibly related to the procedure.This was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
His follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: b5, d1a, d4, h6.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause cannot be conclusively determined and the event cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 2 year(s) post-operative of a left tka, it was reported via clinical study that the patient experienced inflammation and pain.It was further stated - soft tissue retinaculum inflammation gradual onset; left knee - lateral aspect pain.The patient was reviewed with no actions taken and the outcome of this event is considered resolved.The case report form indicates that this event is definitely not related to the device and possibly related to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.

• Brand Name: OPTETRAK LOGIC KNEE COMPONENTS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19317046
• Report Number: 1038671-2024-01253
• Device Sequence Number: 7577777
• Product Code: JWH
• UDI-Device Identifier: 10885862001740
• UDI-Public: 10885862001740
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 02-012-35-2013
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 03/17/2026
• 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
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG