MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HF PS POR FEM, SZ 3, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	OPTETRAK ASY HF PS POR FEM, SZ 3, RIGHT
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 2977658 200-02-32 - three peg patella 32mm 2888552 200-04-33 - cemented finned tib.Tra sz 3f/3t 2831354 244-23-11 - optetrak hi-flex tibial insert sz 3 11mm ***serial number 2831354 is confirmed to have been packaged in a vacuum bag that does not contain evoh.
Event or Problem Description
Per a report from the legal department the patient had an initial right knee replacement on (b)(6) 2014.Approximately 8 years and 4 months later the patient had a right knee revision on (b)(6) 2022 due to loosening and significant synovitis.During the revision surgery, the surgeon noted that there was "found to be grossly loose" and that there was "there was significant synovitis noted and this was debrided and sent for synovial culture." the subsequent post-operative diagnosis confirmed that the patient's right total knee arthroplasty failed due to significant loosening, which is related to the failure in the polyethylene.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Information added to d7a.H6: investigation results - the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not returned for evaluation, and images, radiographs, and operative notes were not provided.Initial submission: fields in section f10 should all be blank, this is a manufacturer's report.

• Brand Name: OPTETRAK ASY HF PS POR FEM, SZ 3, RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16783521
• Report Number: 1038671-2023-00783
• Device Sequence Number: 17562612
• Product Code: JWH
• UDI-Device Identifier: 10885862064622
• UDI-Public: 10885862064622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2015
• Device Model Number: OPTETRAK ASY HF PS POR FEM, SZ 3, RIGHT
• Device Catalogue Number: 246-03-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 06/15/2026
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 09/19/2023; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown