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

Catalog Number	02-010-01-0230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, the 54 year old female patient had an initial left tka on (b)(6) 2012 and presented on (b)(6) 2023 with infection - septic left total knee.The case report form indicates that this event is definitely not related to the device and definitely related to the procedure.It is also indicated that the following action(s) were taken irrigation/debridement/implant removal/antibiotic spacer preimplantation after iv antibiotics for 6 weeks.The outcome of this event was reported as resolved on (b)(6) 2023.(b)(6) 02-010-01-0230 - logic femoral ps cem left sz 3.510k: k033883.No device return anticipated due to being a clinical trial study.
Additional Manufacturer Narrative
(h3) pending evaluation: (d10) concomitant device(s): 2292671 02-010-01-0330 - logic femoral ps cem right sz 3.1913754 02-012-35-3009 - logic tibia ps mod insrt sz 3 9mm.2212610 02-012-44-3011 - logic tibia implant psc insert, sz 3, 11mm.2115059 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t.2293130 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t.2251151 200-02-35 - three peg patella 35mm.2332014 200-02-35 - three peg patella 35mm.2323593 204-34-02 - fluted stem extension 25l x 14 mm.2329343 204-34-02 - fluted stem extension 25l x 14 mm.2336650 204-70-00 - tibial stem ext.Screw.2337588 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The reason for the reported surgery due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.Additionally, infection is a known surgical risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM LEFT 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville 32653 ; 3523771140
• MDR Report Key: 18611539
• Report Number: 1038671-2024-00140
• Device Sequence Number: 12632134
• Product Code: JWH
• UDI-Device Identifier: 10885862001146
• UDI-Public: 10885862001146
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 05/08/2016
• Device Catalogue Number: 02-010-01-0230
• 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: 12/30/2023
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2011
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White