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

Catalog Number	200-02-35
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee replacement on the left side.Subsequently, the patient experienced aseptic patella loosening and lysis around the patella button with displaced fragmentation of the superior pole.As a result, approximately 5.5 years after initial replacement, the patient is rehabilitating through quadriceps exercises.No further impact to the patient was reported.No other information is available.This is 1 of 3 events for this patient.
Additional Manufacturer Narrative
D10: 02-012-35-2011 - logic tibia ps mod insrt sz 2 11mm, 02-010-01-0220 - logic femoral ps cem left sz 2, 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear, patellar loosening, and fracture and/or inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not provided.

• Brand Name: OPTETRAK
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22376749
• Report Number: 1038671-2025-02400
• Device Sequence Number: 19994632
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 08/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 200-02-35
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 59 KG