MAUDE Adverse Event Report: EXACTECH, INC. INSET PATELLA 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-05-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: 02-012-45-4050 logic fit tibial tray sz 4f/5t 4118234; 02-010-03-0240 logic femoral component cr cemented left sz 4 4066829.H3: 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.
Event or Problem Description
It was reported that this patient's left knee was revised 9 years 3 months post initial operation.The patient returned to surgeon office with complaints of stiffness, pain, and dissatisfaction with their total knee replacement.The patient has a recalled polyethylene implant.The patient was scheduled for a revision tka possible polyethylene swap.The patient underwent a tibial polyethylene implant swap and a patella implant swap.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The revision reported was likely the result of tibial insert and patellar prosthesis wear.The observed wear that was observed was most likely due to high contact stress from the femoral component during knee flexion, third body wear, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: INSET PATELLA 29MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21364735
• Report Number: 1038671-2025-00855
• Device Sequence Number: 8482093
• Product Code: JWH
• UDI-Device Identifier: 10885862039859
• UDI-Public: 10885862039859
• 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: 2015
• Device Explanted Year: 2025
• 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): 07/25/2025

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: 03/11/2020
• Device Catalogue Number: 200-05-29
• 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: 01/26/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 03/17/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 252 KG