MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-25-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification, that a patient, who had a left tka system with a 5 hi-flex femur, 5 tibia, 35mm patella, all cemented and a 9mm poly spacer, underwent a revision procedure approximately 4 years 6 months post the initial procedure.The patient presented for evaluation with complaints of mechanical complications and chronic pain.The patient was revised due to implant loosening, (femoral loosening, debonded from cement in one gentle tap), bone loss and significant synovitis.The were revised to a competitor¿s devices.Following the revision surgery, the plaintiff continues to be limited in his activities of daily living, and experiences daily pain and discomfort in his left knee which limits his activities and impacts his quality of life.No further information.This is 1 of 2 events for this patient.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.The reason for the reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and debonding or due to inclusion of the polyethylene in the packaging recall.A contributing factor to the reported wear on the tibial insert may have been due to the revised tibial insert having been packaged in a non-conforming bag for five years.However, the reported prosthesis wear, instability and debonding cannot be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images or radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: OPTETRAK
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25178674
• Report Number: 1038671-2026-00610
• Device Sequence Number: 16127967
• Product Code: JWH
• UDI-Device Identifier: 10885862064073
• UDI-Public: 10885862064073
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 06/03/2018
• Device Catalogue Number: 244-25-09
• 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: 09/08/2022
• Initial Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 06/04/2010
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male