MAUDE Adverse Event Report: EXACTECH, INC. ADVANCED PATELLA 26MM 3 PEG IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-07-26
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation; (d10) concomitant device(s): 7147118 02-020-11-0320 - truliant ps cem fem ps cem right sz 2; 6778800 02-022-45-2015 - truliant tray, cem sz 2f/1.5t; a223511 201-78-15 - holding pin mini sharp point 4 pk; 7309028 201-78-81 - 3" trocar, mod.Hex 2pk; 7309050 201-78-81 - 3" trocar, mod.Hex 2pk; s428025 521-78-23 - threaded pin size 2.3 collared 2pk; 7147118 02-022-35-2011 - truliant tib imp ps insert sz 2 11mm.
Event or Problem Description
It was reported that this 74 y/o female patient's right knee was revised approximately 3 month post op.The patient had an issue with the patella tracking, so the surgeon was going to revise the patella.During surgery he found nothing wrong with the patella implant, excised more tissue around the patella and downsized the 9mm poly.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.Product not returning - the hospital keeps explants.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d, e, g.The patellar tracking issue reported cannot be confirmed and contributing factors from patient or user-related issues cannot be determined because the devices were not available for evaluation and relevant patient information, images, or radiographs were not provided.Patella subluxation may be secondary to a combination of issues including implant alignment, insufficient patellar resection, and/or soft-tissue imbalances.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ADVANCED PATELLA 26MM 3 PEG IMPLANT
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17715824
• Report Number: 1038671-2023-02215
• Device Sequence Number: 6749188
• Product Code: JWH
• UDI-Device Identifier: 10885862314260
• UDI-Public: 10885862314260
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2024
• Device Catalogue Number: 200-07-26
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2019
• 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
• Patient Age: 74 YR
• Patient Sex: Female