MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC TIBIA PS MOD INSRT SZ 3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3013
Medical Device Problem Codes	Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint effusion (4849)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 02-010-01-0230 - logic femoral ps cem left sz 3.02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.200-02-38 - three peg patella 38mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports, also see 1038671-2024-00054.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
Approximately 5 year(s), 5 month(s) and 17 day(s) post-operative of a left tka, it was reported via clinical study that the patient experienced polyethylene wear without evidence of osteolysis.Reduction in bend of left knee with noticeable effusion within joint.The patient underwent left knee arthroscopy, debridement, & biopsy of their left knee as a day case.Patient is still struggling with their knee, effusion remains & reduced flexion.Listed for replacement of polyethene insert +/- revision.The outcome of this event is considered resolved and the case report form indicates that this event is definitely related to the device and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.Reported concomitant device(s): 02-010-01-0230 - logic femoral ps cem left sz 3.02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6.The arthroscopy reported may have been due to the loss of range of motion caused by prosthesis wear of the tibial insert and patella components.However, this cannot be confirmed because the component was not returned for evaluation and no images, radiographs, or relevant product information was provided.Potential contributions of manufacturing, patient, or user-related issues to the event could not be determined from the reported information.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 TIBIA PS MOD INSRT SZ 3 13MM
• 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
• MDR Report Key: 20885992
• Report Number: 1038671-2024-04721
• Device Sequence Number: 12971627
• Product Code: JWH
• UDI-Device Identifier: 10885862001825
• UDI-Public: 10885862001825
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 02-012-35-3013
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 04/24/2025
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG