MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3 (b)(6) 02-012-39-3030 - logic tibia fin tray cem sz 3f/3t (b)(6) 200-02-35 - three peg patella 35mm (b)(6) 201-78-12 - holding pin lg head sharp point med 2pk (b)(6) 201-78-15 - holding pin mini sharp point 4 pk (b)(6) 201-78-80 - 3" trocar, hex 2pk.(b)(4).201-78-80 - 3" trocar, hex 2pk.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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 who had a right total knee arthroplasty, underwent a revision procedure, approximately 11 years 10 months post the initial procedure.The patient had sepsis of the right knee.A washout and poly swap of the same size implant was performed by the surgeon.There was no device breakage or surgical delay during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted device is not available for return as the hospital won¿t release the device.A device image was provided.No further information.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 11MM
• 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: goeff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23418254
• Report Number: 1038671-2025-03240
• Device Sequence Number: 21434473
• Product Code: JWH
• UDI-Device Identifier: 10885862001818
• UDI-Public: 10885862001818
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2025
• 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): 10/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2020
• Device Catalogue Number: 02-012-35-3011
• 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: 10/14/2025
• Initial Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 06/23/2012
• 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; Congenital Anomaly
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 82 KG