MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 4 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint effusion (4849)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: (b)(6), 02-010-01-0240 - logic femoral ps cem left sz 4; (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6), 200-02-32 - three peg patella 32mm.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2012, and then experienced revision surgical procedure on (b)(6) 2023 approximately 11 years after initial implant.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21412123
• Report Number: 1038671-2025-01080
• Device Sequence Number: 15584347
• Product Code: JWH
• UDI-Device Identifier: 10885862001900
• UDI-Public: 10885862001900
• Combination Product (Y/N): N
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 05/24/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• Device Catalogue Number: 02-012-35-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 02/19/2025
• Date Device Manufactured: 05/24/2010
• 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: 72 YR
• Patient Sex: Male