MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-44-3013
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6)2015 and then approximately 8 years, 2 months later they experienced a revision surgical procedure on (b)(6)2023.Patient was revised to competitor¿s devices.Revision operative report of (b)(6)2023-postoperative diagnosis: right failed total knee arthroplasty.Indication: 87 y.O.Female who was seen in the office with a failed right total knee replacement refractory to conservative management.Imaging was consistent with failed right knee arthroplasty.Procedure: a thorough synovectomy was performed.Removal of implants.The polyethylene insert was removed with a thin bent retractor.The femoral component was removed by hand.Attention was then turned to the tibia; using the small saw and osteotomes, the tibia was removed with minimal bone loss.The patella was debrided of scar tissue and the button was removed with a saw.Implants were trialed and new devices implanted.Dressings were applied.The patient was transferred to the recovery room in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.H6.Investigation results- the logic device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s 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.The revision operative report received does not mention any specific failures of the exactech devices found during the revision.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, d10.The following sections were corrected: d1, d2b, d4, g2, g4, h4, h6.D10: 02-012-35-3011 - logic tibia ps mod insrt sz 3 11mm.02-012-41-3030 - logic tibia traptray cem sz 3f/3t.
Event or Problem Description
Additional information received from the facility states the patient was revised due to mechanical loosening of internal right knee prosthetic joint, or femoral debonding/loosening.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3
• 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17258979
• Report Number: 1038671-2023-01539
• Device Sequence Number: 20803908
• Product Code: JWH
• 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: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

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: 07/14/2019
• Device Model Number: 02-012-44-3013
• Device Catalogue Number: 02-010-01-0330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 11/03/2025; Not provided
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 11/11/2025; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female