MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-01-0320 - logic femoral ps cem right sz 2.02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.200-02-35 - three peg patella 35mm.999 - femoral stem.
Event or Problem Description
The following actions were taken: approximately 5 years and 9 months post-op the patient underwent arthroscopy and debridement with a biopsy.Approximately 8 months later, the patient was reviewed in clinic and has been listed for revision of the right knee +/- poly exchange alone.Finally, the patient underwent revision surgery in late summer of 2023.The outcome of this event is now considered resolved and the clinical study report indicates that this event is definitely related to the device and definitely not related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20137569
• Report Number: 1038671-2024-03279
• Device Sequence Number: 11538488
• Product Code: JWH
• UDI-Device Identifier: 10885862001733
• UDI-Public: 10885862001733
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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 Catalogue Number: 02-012-35-2011
• 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: 10/05/2022
• Initial Report FDA Received Date: 09/04/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 67 KG