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 Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-01-0350 - logic femoral ps cem right sz 5; (b)(6) - 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm; (b)(6) - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-01573, 1038671-2024-00167.The reason for the revision reported was likely due to the reported pain, and possibly femoral loosening.Prosthesis wear is a potential contributing factor but likely an incidental finding.Failure of the cement used to secure the implants to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the pain, prosthesis wear and femoral loosening could not be determined as the devices were not returned 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
It was reported that approximately 107 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is 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: 21607494
• Report Number: 1038671-2025-01574
• Device Sequence Number: 21196298
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• 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: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2020
• 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: 01/09/2024
• Initial Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 01/26/2015
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 108 KG