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

Catalog Number	02-010-04-0240
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had an initial left total knee arthroplasty on (b)(6) 2020 and then approximately 1 year, 9 months later on (b)(6) 2022 the patient experienced a revision surgical procedure.The patient was revised to competitor devices.Revision operative report of 26 apr 2022- failed tka secondary septic loosening.X-rays demonstrated loosening of tibial as well as patellar component.Aspirated knee, it was significant for red blood cells as well as 12,000 white blood cells with 100% neutrophil differential- nothing grew from the aspiration.Patellar component was completely loose.Removed any remaining cement.Femoral component was grossly loose.Removed it as well as the fibrous tissue underneath it all the way back to bone.Removed the tibial component, it was grossly loose.Sterile dressing was applied.No apparent complications noted.There is no clinical/patient medical information provided.There is no other information available.
Additional Manufacturer Narrative
D10.Concomitants: optetrak logic tibial insert (02-012-51-4013, 4141935); optetrak 3 peg patella (200-02-32, 6529350); optetrak logic fit tibial tray (02-022-45-4030, 5281680); palacos r&g bone cement x 2.H3.Investigation results- the cause of the patient¿s infection/septic loosening and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.There is no clinical/patient medical information provided.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, instability and tibial loosening, and patellar loosening.Or due to inclusion of the polyethylene in the packaging recall.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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR FEMORAL POR, LEFT, 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 18988700
• Report Number: 1038671-2024-00681
• Device Sequence Number: 2833358
• Product Code: JWH
• UDI-Device Identifier: 10885862158277
• UDI-Public: 10885862158277
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2024
• Device Catalogue Number: 02-010-04-0240
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 10/25/2019
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female