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 Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-020-12-0350 - truliant ps por fem ps por right sz 5 5815153.02-022-55-5040 - truliant por tib tray size 5f/4t 5991400.02-029-99-1001 - fluted headless pin 3.0" square head 015979.02-029-99-1002 - threaded head pin 2.3" square head 359010.
Event or Problem Description
It was reported that this patient's right knee was revised approximately 4 years post op.Surgeon performed insert and patella exchange.Patella was converted to competitors device.Insert was replaced with exactech insert.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision was likely the result of tibial insert and patella component inclusion in the packaging recall and potential prosthesis wear.Possible causes of the potential polyethylene wear include third body wear, patient-related factors, the inclusion of the polyethylene in the packaging recall and/or any combination of these possibilities.However, the prosthesis wear was unable to be confirmed based on the provided information.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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20615150
• Report Number: 1038671-2024-04248
• Device Sequence Number: 20716613
• 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: 2020
• Device Explanted Year: 2024
• 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): 09/30/2025

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: 05/25/2025
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 75 KG