MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 41MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-41
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 142 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear and pain.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-01-0240 - logic femoral ps cem left sz 4.(b)(6) - 02-012-35-4013 - logic tibia ps mod insrt sz 4 13mm.(b)(6) - 02-012-41-4030 - logic tibia traptray cem sz 4f/3t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00050.The revision reported may have been the result of patella wear and an insufficient bone between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening after being implanted for nearly 12 years.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs/operative notes were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: THREE PEG PATELLA 41MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21400441
• Report Number: 1038671-2025-00934
• Device Sequence Number: 20905701
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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: 01/12/2014
• Device Catalogue Number: 200-02-41
• 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: 01/03/2023
• Initial Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 01/13/2009
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male