MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-010-01-0340, logic femoral ps cem right sz 4, 4868915, 02-012-41-4040, logic tibia traptray cem sz 4f/4t, 4818907, 200-02-35, three peg patella 35mm, 4970560.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that a male patient, initial right knee implanted on (b)(6) 2017, was revised on (b)(6) 2022, approximately 4 years 4 months post the initial procedure.The reported information indicated that in the middle of 2020, the patient began experiencing severe pain, swelling, and instability in his right knee.An mri performed on (b)(6) 2021, on the patient¿s right knee demonstrated a ¿polymeric-induced synovitis¿, ¿focal femoral osteolysis, and prominent fibrous interface over the patella components¿, ¿deficiency of the fibular collateral ligament and degeneration of the popliteus tendon.¿ the patient's clinical, laboratory, and radiological workup on his right knee was negative for infection, but positive for loosening secondary to osteolysis secondary to polyethylene wear.No device returning due to this being a legal case.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and insufficient bonds between the implant and the bones which led to aseptic (non-infected) loosening.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 extent and root cause of the prosthesis wear, osteolysis, and loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have been the result of prosthesis wear, osteolysis, and insufficient bonds between the implant and the bones which led to aseptic (non-infected) loosening.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC
• 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
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15777282
• Report Number: 1038671-2022-01449
• Device Sequence Number: 12447772
• Product Code: JWH
• UDI-Device Identifier: 10885862173669
• UDI-Public: 10885862173669
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 08/31/2024
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
• Device Catalogue Number: 02-012-44-4015
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/17/2023; 04/16/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/07/2023; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male