MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-02-03
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	11/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 9 years post initial left total knee arthroplasty (tka) using cr slope with tibial insert, the patient complained of knee swelling and pain.The surgeon diagnosed the wear of the tibial insert, then revision surgery for the replacement of all knee device was performed.Breakage and wear was observed in the retrieved tibial insert.Also, damage was observed in posterior of tibial tray due to contacting to the femoral component.The surgeon decided to replace all components with a competitor prosthesis.The tibial tray was damaged and found metal powder.The surgeon retrieved and cleaned it appropriately during the surgery.The patient's bone quality was normal and the patient had high activity level.It was also noted that the patient had not worn a knee brace following surgery.The event did not lead to surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Operative notes and/or medical records were not provided for review of usage/ technique.The revision reported was likely the result of full thickness prosthesis wear of the posterior edge of the tibial insert and subsequent wear between the tibial tray and femoral component secondary to contributions from instability and/or combined tibial slope leading to articulation of the femoral component on the posterior edge of the tibial insert.However, the contributions of instability or component positioning to the sequence of events cannot be confirmed as the devices were not available for evaluation and neither radiographs nor clinical information was provided.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3,
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21280317
• Report Number: 1038671-2025-00588
• Device Sequence Number: 9320409
• Product Code: JWH
• UDI-Device Identifier: 10885862061683
• UDI-Public: 10885862061683
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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 Expiration Date: 07/12/2020
• Device Catalogue Number: 230-02-03
• 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: 11/06/2024
• Initial Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 07/15/2015
• 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
• Patient Sex: Female
• Patient Weight: 58 KG