MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3515
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 2660361, 02-010-01-0235 - logic femoral ps cem left sz 3.5.2584122, 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.2550804, 200-05-29 - inset patella 29mm.2452386, 204-32-04 - stem extension 40l x12mm.2412973, 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
As reported by legal, approximately 4 years post op the initial left tka, this male patient underwent a revision and a new optetrak device tibial insert was placed.Reason for the revision was not reported.Upon information and belief, patient required several revision surgeries for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.
Additional Manufacturer Narrative
H3: the logic device with serial number (b)(6), is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Investigation results - the revision reported was likely the result of prosthesis wear.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 implanted patella was reported to be undersized, which could also be a contributing factor to the prosthesis wear.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.
Event or Problem Description
Revision op report of 4 may 2017-findings: there was found to be polyethylene wear of the tibial component with creep of the posterior polyethylene as well as wear of the tibial post.There was slight varus/valgus laxity with the existing component.The femoral component and tibial components themselves were found to be well fixed.The patella was found to be somewhat undersized with bony overgrowth.This was revised.Ultimate reconstruction with a 17 mm polyethylene allowed full extension, no recurvatum, flexion of 125 degrees with excellent stability and excellent tracking.Sterile bandages were applied and the patient was transferred to the recovery room in stable condition.
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, prosthesis wear and extraskeletal ossification.As a result, the patient underwent a left knee revision approximately 3 years and 11 months after initial implantation.No further patient impact reported.No further information available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16478431
• Report Number: 1038671-2023-00341
• Device Sequence Number: 16943664
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 10/29/2020
• Device Catalogue Number: 02-012-35-3515
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 12/04/2023; 09/16/2026
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/19/2023; 12/19/2023; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male