MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 41MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	THREE PEG PATELLA 41MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2016.Approximately 7 years after the initial procedure the patient had a left knee revision on (b)(6) 2023.The patient has suffered the following injuries and complications: daily pain and discomfort in his left knee.The patient has suffered debilitating injures and damages, including but not limited to, pain and discomfort, swelling, gait impairment; poor balance; component part loosening; soft tissue damage; bone loss; bone damage.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: 2144076 02-012-47-5009 - logic cr tib insert std, sz 5, 9mm; 4300108 02-010-03-0250 - logic cr femoral cem, left; 4139909 204-70-00 - tibial stem ext.Screw; 4161516 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t; 4331326 204-32-01 - fluted stem extension 11l x 12 mm; aa9835 1400-ag - cemex gento low viscosity 40g kit.

• 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 INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21307210
• Report Number: 1038671-2025-00646
• Device Sequence Number: 12973943
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: THREE PEG PATELLA 41MM
• Device Catalogue Number: 200-02-41
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 03/10/2016
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male