MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-04-33
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Swelling/ Edema (4577); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 200-23-15 - cr tibial insert sz3, 15mm ((b)(6)); 200-01-03 - cemented cr femoral sz 3 ((b)(6)); 200-04-33 - cemented finned tib.Tra sz 3f/3t ((b)(6)); 200-05-26 - inset patella 26mm ((b)(6)).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01334.The revision reported was likely the result of prosthesis wear of the tibial insert, osteolysis, and tibial loosening.The wear may have been due to a combination of third body wear, positioning of the components, instability, and/or patient related conditions.The reported aseptic (non-infected) tibial loosening/osteolysis may have been due to an insufficient bond between the tibial tray and the bone.However, this cannot be confirmed.It is unclear if the reported loosening may have contributed to the wear or if the wear may have contributed to the reported loosening.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
Report #1 of 2 for this event.It was reported a patient had an initial right total knee arthroplasty.Subsequently, the patient experienced aseptic (non-infected) loosening, pain, swelling, stiffness and prosthesis wear.As a result, approximately on an unknown date, the patient underwent a right knee revision procedure.It was reported the tibial insert component had significant wear and the tibial tray component was loose.It was reported the patient presents to be doing well post the right knee revision.The patient was revised to another manufacturer's construct.No additional information is available.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 3F/3T
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24638997
• Report Number: 1038671-2026-00297
• Device Sequence Number: 9876728
• Product Code: JWH
• UDI-Device Identifier: 10885862039736
• UDI-Public: 10885862039736
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 03/19/2026

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: 08/20/2016
• Device Catalogue Number: 200-04-33
• 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: 09/30/2022
• Initial Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 08/23/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 107 KG