MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-25-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 1292007 204-34-02 - fluted stem extension 25l x 14 mm.1450562 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
It was reported that a patient, initial right knee implanted in (b)(6) of 2009, underwent a revision procedure approximately 15 years post the initial procedure.Revision date unknown.The surgeon removed the optetrak ps knee due to poly wear.There were signs of wear on the patella and liner.There were also signs of metallosis.There was an absence of cement on a significant portion of the backside surface of the femoral component.The surgeon replaced all components with a competitor¿s devices.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for return.Legal indicated for the reason.Device images were provided.
Additional Manufacturer Narrative
The revision reported was likely the result of tibial insert wear leading to insert fracture and metal-on-metal wear.Patellar wear was also observed per the provided images.Possible causes for the observed polyethylene wear included high contact stress during knee flexion and extension on the posterior end of the insert, high forces on the patellar component, patient-related factors, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.B3: corrected.D1: corrected.H6: corrected component and investigation clinical codes.

• Brand Name: PS TIBIAL INSERTS SZ 5, 9MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19620689
• Report Number: 1038671-2024-02156
• Device Sequence Number: 8085184
• Product Code: JWH
• UDI-Device Identifier: 10885862048462
• UDI-Public: 10885862048462
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 03/28/2016
• Device Catalogue Number: 204-25-09
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2008
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 56 KG