MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 3.5
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2013, patient underwent bilateral total knee replacement surgeries.After patient¿s right knee revision, her left knee began to hurt.On (b)(6) 2023, patient had her left knee evaluated by an orthopedic surgeon.X-rays performed as a part of that evaluation revealed osteolysis.Patient is currently in the process of scheduling a revision surgery for her left knee.
Additional Manufacturer Narrative
Concomitant medical products: logic tibia ps mod insrt sz 3.5 11mm (cat# 02-012-35-3511 / serial#: (b)(4), lgc tibial fit tray cem sz 3.5f / 2.5t (cat# 02-012-45-3525 / serial# (b)(4), three peg patella 35mm (category #: 200-02-35 / serial# (b)(4), three peg patella 32mm (category# 200-02-32 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The reported laxity could also be a potential contributing factor.The extent and root cause of the prosthesis wear and the osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Event or Problem Description
As reported via legal documentation, a patient had left knee replacement surgery on (b)(6) 2013.They subsequently underwent left knee revision surgery on (b)(6) 2023, approximately 9 years 4 months post initial implantation.Revision op report postoperative diagnosis: accelerated polyethylene wear, left total knee replacement.Pre-revision investigation revealed osteolysis under the tibial as well as femoral components.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16382160
• Report Number: 1038671-2023-00174
• Device Sequence Number: 6279253
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 08/28/2020
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 3.5
• Device Catalogue Number: 02-012-35-3511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 09/09/2026
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 11/09/2023; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female