MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-38
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6), 204-70-00 - tibial stem ext.Screw.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 02-010-01-0240 - logic femoral ps cem left sz 4.(b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.The reason for the revision reported was likely due to the reported instability and prosthesis wear, or inclusion of the polyethylene implants in the packaging recall.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a male patient, initial left knee implanted and then underwent a revision procedure approximately 7 years 4 months post the initial procedure.Reason for revision indicated instability with the patella, clicking, and the poly recall.The patient was revised to a size 4 constrained femur with an 18 x 1 20 stem a medium 32 cone and a 4\19 mm constrained poly.There were no device breakages or surgical delays.The patient was last known to be in stable condition following the event.No x-rays provided.The explanted devices are not available for return as they were not made available.Device images were provided.No further information.Device images, ebi surgery results, & qad serial trace attached.No x-rays available.

• Brand Name: THREE PEG PATELLA 38MM
• 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: 22961665
• Report Number: 1038671-2025-02877
• Device Sequence Number: 8453454
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: 02/28/2021
• Device Catalogue Number: 200-02-38
• 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: 10/12/2023
• Initial Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 03/02/2016
• 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 Age: 61 YR
• Patient Sex: Male