MAUDE Adverse Event Report: Exactech, Inc. THREE PEG PATELLA 32MM; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	200-02-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient had an initial left total knee arthroplasty.Subsequently, eleven (11) years nine (9) months later, the patient was revised due to polyethylene flaking and delamination.The patella and tibial insert components were replaced.Patient was last known to be in stable condition following the event.(b)(6) 204-24-09 tibial insert posterior stabilized sz 4, 9mm ***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k933610 udi:(b)(4).Concomitants: 2025330 204-04-45 tibial tray trapezoid, cemented.2232579 234-02-04 asymmetric femoral posterior stabilized, cemented sz 4 left.2228270 200-02-32 3 peg patella, cemented 32mm.

• Brand Name: THREE PEG PATELLA 32MM
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 50212473
• Report Number: 1038671-2026-01018
• Device Sequence Number: 14980112
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2017
• Device Catalogue Number: 200-02-32
• 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: 12/10/2023
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 01/23/2012
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 220 LB