MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK CC; SEE H10

Model Number	CC TIBIAL INSERT SZ 2, 15MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.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 patient, underwent left total knee revision surgery due to a ¿left knee aseptic loosening" on (b)(6) 2017.Upon removal of the original tibial insert, plaintiff was implanted with a second recalled optetrak device in her left knee.Plaintiff¿s revision surgery was due to accelerated and preventable wear of the defective polyethylene insert component within the optetrak device.Following her revision surgery, plaintiff continued to experience pain in her left knee, and plaintiff will be proceeding with a re-revision surgery to remove the second recalled optetrak device implanted in her left knee.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Additional information: a3, & b7 h6.Investigation - 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 patient¿s pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.H6.Health effect - impact code-patient was not revised/ chronic disease-pain.

• Brand Name: OPTETRAK CC
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16459655
• Report Number: 1038671-2023-00294
• Device Sequence Number: 2393723
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 04/15/2019
• Device Model Number: CC TIBIAL INSERT SZ 2, 15MM
• Device Catalogue Number: 208-22-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 04/23/2023; 06/11/2026
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/23/2023; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-20
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female