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)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 63 yo male patient, initial left tka implanted in (b)(6) 2017, underwent a revision procedure in (b)(6) 2025, approximately 7 years 5 months post the initial procedure.The patient had returned to the surgeon¿s 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 tibial polyethylene implant and a patella implant were swapped.The polyethylene was broken in pieces posteriorly, the pieces of the implant and polyethylene were removed from the wound site, and the knee joint was irrigated well.They were replaced with a tibial insert sz 5, 10mm, and a 3 peg patella cemented 38 mm.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the procedure.No x-rays were provided.The explanted devices are not available for return as they were sent to the lab at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 02-012-45-5050, logic fit tibial tray sz 5f/5t (b)(6); 02-010-03-0250, logic femoral component cr cemented left sz 5 (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the revision reported was likely due to the reported pain caused by prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene damage include inclusion of the polyethylene in the packaging recall, malalignment between 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: 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
• MDR Report Key: 21363750
• Report Number: 1038671-2025-00845
• Device Sequence Number: 8519001
• 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): 04/02/2025

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: 04/28/2022
• 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: 04/01/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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: 116 KG