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); Discomfort (2330)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a 63 yo male patient, initial right tka in (b)(6) 2017, underwent a revision procedure in (b)(6) 2025, approximately 7 years 11 months post the initial procedure.The patient returned to the surgeon with complaints of stiffness, pain, and dissatisfaction with their total knee replacement.The patient has a recalled poly implant.They were scheduled for a revision tka, possible poly swap.The patient had revision surgery in (b)(6) 2025 and the poly implant and patella implant were swapped.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.They were sent to the lab at the hospital.Device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-03-0350 - logic cr femoral cem, right, sz 5, (b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6), 02-012-49-5009 - logic cr tib insert slope++, sz 5, 9m.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
The pain and subsequent revision reported was likely the result of prosthesis wear of the tibial insert and the patella.Possible causes for polyethylene wear include high contact stresses during knee flexion, third body wear, or any combination of these possibilities.Contributions from the overall slope of the insert may have allowed for excessive posterior articulation leading to wear of the polyethylene insert.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.H6: corrected 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21856360
• Report Number: 1038671-2025-01804
• Device Sequence Number: 20793855
• 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: 2017
• 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): 07/15/2025

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: 09/15/2020
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 110 KG