MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-29
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d.The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be instability and inclusion of the polyethylene in the packaging recall.However, the reported instability could not be confirmed from the provided information.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, 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 approximately 99 months after a right total knee replacement procedure, the patient underwent a revision procedure to address possible symptomatic polyethylene wear, including pain, swelling, instability, and dissatisfaction with their tka.Revision operative notes were provided.Findings indicated mild synovitis and no purulence.There was mild wear of the tibial polyethylene involving the posterior aspect, particularly on the medial aspect, with some evidence of oxidation.The locking mechanism appeared to be intact.The femoral and tibial components were found to be well-fixed.There was only minimal wear of the patella involving the central aspect.The surgeon performed an exchange of the tibial and patella polyethylene.The patient was then awoken from sedation and transferred to recovery in stable condition.The devices were not returned for evaluation, as they were sent to the lab and legal at the hospital.Images and x-rays were provided for review.No further issues or complications were reported no additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-03-0335 - logic cr femoral cem, right, sz 3.5, (b)(6) - 02-012-49-3509 - logic cr tib insert slope ++, sz 3.5, 9 mm, (b)(6) - 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00553.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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 29MM
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22994198
• Report Number: 1038671-2025-02887
• Device Sequence Number: 8833641
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/18/2025

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: 12/11/2019
• Device Catalogue Number: 200-02-29
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 76 KG