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	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) - 02-010-01-0230 - lgc femoral ps cem left sz 3, (b)(6) - 02-012-43-3020 - lgc tibia rbktray cem sz 3f/ 2t, (b)(6) - 00-02-32 - three peg patella 32mm, (b)(6) - 201-78-15 - holding pin mini sharp point 4 pk, (b)(6) - 521-78-23 - threaded pin size 2.3 collared, (b)(6) - 521-78-23 - threaded pin size 2.3 collared, (b)(6) - 521-78-32 - threaded pin size 3.0 collarless, (b)(6) - 521-78-32 - threaded pin size 3.0 collarless, 2031017019 - (b)(6) - gps implant kit v2.The revision reported was likely the result of tibial insert prosthesis wear.Additional reasons for the reported revision may be patella prosthesis wear, patient related conditions or any combination of these possibilities.However, the patella wear could not be confirmed from the provided information.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation.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
As reported, approximately 6.5 years post op initial left tka, this patient was revised due to poly delamination and patella/poly wear.The patient was revised to a size 3, 11mm tibial insert.Patient was last known to be in stable condition following the event.

• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22140502
• Report Number: 1038671-2025-02233
• Device Sequence Number: 12797054
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2021
• 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: 11/27/2023
• Initial Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 07/07/2016
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 87 KG