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

Model Number	TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal notification, that patient, in or around (b)(6) 2012, required a revision procedure after it was discovered that the plastic tibial insert of the defective optetrak total knee system implant had failed, during which the prior right knee prosthetic device was revised and the plastic tibial insert was replaced with the optetrak tibial insert (204-04-23) (hereinafter referred to as the ¿2012 defective implant¿).On or around, (b)(6) 2020 plaintiff required a second revision procedure, approximately 7 years 10 months post procedure, during which the total knee prosthesis was completely removed.Pathology taken during the (b)(6) 2020 surgery revealed that the explanted tibial component (204-04-23) had focal pitting and scratches with delamination predominantly on the medial compartment.The patellar component also showed wear deformation.No device return anticipated due to this being a legal case.No further information.
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.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, instability, and loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.H6: corrected health effect, medical device, component, and investigation clinical codes.
Additional Manufacturer Narrative
H6: corrected health effect : clinical code and type of investigation code.

• Brand Name: OPTETRAK
• 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: 16491866
• Report Number: 1038671-2023-00365
• Device Sequence Number: 6844440
• Product Code: JWH
• UDI-Device Identifier: 10885862047649
• UDI-Public: 10885862047649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• 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): 09/10/2024

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 Model Number: TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T
• Device Catalogue Number: 204-04-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 09/09/2024; 09/09/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 09/10/2024; 09/10/2024
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown