MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-03-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Loss of Range of Motion (2032); Synovitis (2094); Skin Inflammation/ Irritation (4545); Radiolucent Lines (4848)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: c040140g - orthocem g1 standard viscosity cement.204-63-05 - tibial augment block 1/2-sz 3 5mm.200-02-35 - three peg patella 35mm.204-63-05 - tibial augment block 1/2-sz 3 5mm.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.
Event or Problem Description
As reported, the implant failed clinically, resulting in major bone osteolysis and necessitating revision surgery.Everything was fine until about 1.5 years ago when pain, effusion and decreased mobility began.X-ray showing osteolysis of the posterior condyles; comparing this x-ray with the one from 2019, degeneration is evident.Radiolucent lines are seen surrounding both components, which should be evaluated clinically (possible loosening?).Bone biopsies and microbiological and histological studies rule out infection.Infectious complication; fall; pressure ulcer; surgical wound inflammation; reintervention.Removal of ptj dta with findings of extensive synovitis and massive tibial and femoral osteolysis and revision arthroplasty with cemented tibia and femoral sleeve.There was no reported breakage of a device or surgical delay/prolongation.The patient required prolonged hospitalization as a direct result of this issue.The patient suffered permanent disability as direct result of this event.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23827463
• Report Number: 1038671-2025-03572
• Device Sequence Number: 5093784
• Product Code: JWH
• UDI-Device Identifier: 10885862063854
• UDI-Public: 10885862063854
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 02/20/2023
• Device Catalogue Number: 244-03-04
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG