MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-23-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 1823634 200-04-33 - cemented finned tib.Tra sz 3f/3t.1825598 234-03-03 - optetrak asy, ps cemented femoral, sz 3.
Event or Problem Description
Approximately 14 years after a right total knee replacement, the patient returned with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled poly implant.Upon examination, the patient underwent a poly tibial insert swap and patella swap.The event is not related to the breakage of a device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely due to the prosthesis wear and instability or due to the inclusion of the polyethylene in the packaging recall.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 3, 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: 19621172
• Report Number: 1038671-2024-02164
• Device Sequence Number: 18163853
• Product Code: JWH
• UDI-Device Identifier: 10885862048301
• UDI-Public: 10885862048301
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• 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): 05/05/2025

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: 07/06/2018
• Device Catalogue Number: 204-23-09
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2010
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 91 KG