MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0340
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: optetrak logic tibial tray (02-012-41-4040, (b)(6), optetrak logic tibial insert (02-012-44-4011, (b)(6), optetrak 3 peg patella (200-02-32, (b)(6), logic tibia implant psc (02-012-44-4013-)- sn (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01078.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening.The reported prosthesis wear, instability, and femoral loosening could not be confirmed.Potential contributions of user- and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.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 a patient had a right knee revision procedure five (5) years after the initial implant.The tibial insert component was exchanged due to prosthesis wear.Subsequently, three (3) years later, the patient experienced pain and swelling.As a result, the patient underwent a second (2nd) right knee revision procedure due to prosthesis wear.Intraoperatively, synovitis, osteolysis and femoral component loosening was observed.The tibial insert component was exchanged.The patient was transferred to the recovery room in stable condition.No further patient impact was reported.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 4
• 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
• Manufacturer Contact: 2320 nw 66th ct; gainesville, FL
• MDR Report Key: 24658264
• Report Number: 1038671-2026-00308
• Device Sequence Number: 9198612
• Product Code: JWH
• UDI-Device Identifier: 10885862001252
• UDI-Public: 10885862001252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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): 03/22/2026

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: 12/10/2017
• Device Catalogue Number: 02-010-01-0340
• 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: 03/01/2023
• Initial Report FDA Received Date: 03/22/2026
• Date Device Manufactured: 12/12/2012
• 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: Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Male