MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.Z-0019-2022.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that a male patient, initial left knee implanted on (b)(6) 2007, underwent a revision procedure on (b)(6) 2022, approximately 15 years post the initial implant procedure for reasons unknown.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, d6b, g2, h6 : clinical code, medical device problem code, component code and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK HI-FLEX
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: ashley harris ; 3523771140
• MDR Report Key: 15583931
• Report Number: 1038671-2022-01292
• Device Sequence Number: 17738723
• Product Code: JWH
• UDI-Device Identifier: 10885862064035
• UDI-Public: 10885862064035
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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: 06/18/2012
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM
• Device Catalogue Number: 244-24-09
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 03/05/2026
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/10/2022; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2007
• 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; Required Intervention
• Patient Sex: Male