MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PS INSERT SZ 1.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-35-1509
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that the 78 yo female patient had an infection.On (b)(6) 2022, she went to the icus due to pain in her right knee, functional limitation and that on examination redness and suppuration of material from the proximal part of the herdia was evidenced, a cure was performed, and samples were taken for culture.On (b)(6) 2022, surgical debridement and new sampling for culture was carried out.Debridement is repeated on (b)(6) 2022, performing dair with change of moving parts.The outcome was last known as resolved on (b)(6) 2023.
Additional Manufacturer Narrative
Concomitant medical products: 02-010-01-0315 - logic femoral ps cem right sz 1.5; 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; no device information was provided.The cause of the patient¿s infection 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.These devices are used for treatment not diagnosis.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported via clinical study that the 78 yo female patient had an infection.On (b)(6) 2022, she went to the icus due to pain in her right knee, functional limitation and that on examination redness and suppuration of material from the proximal part of the herdia (wound) was evidenced, a cure was performed, and samples were taken for culture.On (b)(6) 2022, surgical debridement and new sampling for culture was carried out.Debridement is repeated on (b)(6) 2022, performing dair ((debridement, antibiotics and implant retention) with change of moving parts.The outcome was last known as resolved on (b)(6) 2023.The case report form indicates this event is unlikely related to device and unlikely related to procedure.
Event or Problem Description
It was reported via clinical study that the 78 yo female patient had an infection.On (b)(6) 2022, she went to the icus due to pain in her right knee, functional limitation and that on examination redness and suppuration of material from the proximal part of the herdia (wound) was evidenced, a cure was performed, and samples were taken for culture.On (b)(6) 2022, surgical debridement and new sampling for culture was carried out.Debridement is repeated on (b)(6) 2022, performing dair ((debridement, antibiotics and implant retention) with change of moving parts.The outcome was last known as resolved on (b)(6) 2023.The case report form indicates this event is unlikely related to device and unlikely related to procedure.
Additional Manufacturer Narrative
The reason for the reported surgical intervention due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.D1: corrected.H4: unknown.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC PS INSERT SZ 1.5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: geoff gannon ; gainesville 32653
• MDR Report Key: 16527321
• Report Number: 1038671-2023-00410
• Device Sequence Number: 19488314
• Product Code: JWH
• UDI-Device Identifier: 10885862180759
• UDI-Public: 10885862180759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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 Catalogue Number: 02-012-35-1509
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 06/24/2025
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 12/01/2023; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic