MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-03-04
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Discomfort (2330); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 111 months after a right knee replacement procedure.The patient did very well initially, but has developed increasing discomfort and polyethylene wear was indicated by x-ray.A revision op report was provided.A revision total right knee and autologous platelet tissue grafting was performed.Intraoperatively the surgeon observed significant metal staining on all surfaces of the synovium.The polyethylene was noted to be damaged posteromedially.It was noted there was no bone loss from either the femur or tibial for removal of those components.The patient was revised to an exactech construct and noted to be seated well.The patient was awakened and taken to the recovery room in stable condition.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6), 620-00-02 - platelet rich plasma kit with spray tips, (b)(6), 200-02-38 - three peg patella 38mm, (b)(6), 200-04-44 - cemented finned tib.Tra sz 4f/4t, (b)(6), 620-11-02 - accelerate conc.Sys rep by 620-12-02.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2024-01616.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4,
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21936995
• Report Number: 1038671-2025-01943
• Device Sequence Number: 18102252
• Product Code: JWH
• UDI-Device Identifier: 10885862061768
• UDI-Public: 10885862061768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• 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): 04/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2014
• Device Catalogue Number: 230-03-04
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 11/17/2009
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male