MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Osteolysis (2377)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported a patient had an initial left total knee arthroplasty.Subsequently, eight (8) years later, the patient complained of pain and joint effusion.As a result, the patient underwent a revision of the procedure.A revision operative report was provided.Post operative diagnoses notes failed left total knee arthroplasty secondary to polyethylene wear, femoral osteolysis, and loose femoral component.Intraoperatively, significant osteolytic debris in the synovium was observed.The patella was found to be well fixed with no wear.The insert was removed and found to have oxidation and delamination.The tibia was solid, but the femoral component easily removed from the cement mantle.When resecting the lateral side beneath the cement, there was a large uncontained posterolateral osteolytic cyst which was debrided back to healthy bone and the defect corrected with cement.The patient was awakened and taken to the recovery room in stable condition.Radiograph and images were provided.No additional information is available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 9MM
• 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: julia golberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25364134
• Report Number: 1038671-2026-00691
• Device Sequence Number: 13274112
• Product Code: JWH
• UDI-Device Identifier: 10885862001726
• UDI-Public: 10885862001726
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 12/13/2020
• Device Catalogue Number: 02-012-35-2009
• 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: 03/09/2023
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 12/18/2012
• 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: 70 YR
• Patient Sex: Female