MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT; SEE H10

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	05/27/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification, that a patient, underwent a bilateral knee replacement initial surgery on (b)(6) 2014.The patient was implanted with a optetrak devices.Specifically, implanted with a optetrak posterior stabilized tibial insert, along with optetrak stems, optetrak patellas, optetrak screws, optetrak tibial trays, and optetrak posterior stabilized femoral components.Following the surgery, the patient began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.The patient continues to experience pain and discomfort on a daily basis in both of her knees which limits her daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Additional information: a2, a3, b5, b7, d1, d4 all, g4 510k, h4, h6 investigation results, h7, h9 h6.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the patient pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient has bilateral knee replacements, this suggests joint maladies.These devices are used for treatment not diagnosis.H6.Health effect - impact code- 4614 "[the patient is not revised]".
Event or Problem Description
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.Additional information received via legal department: initial implant operative report added to b7.
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 prosthesis wear, pain, instability, effusion, ambulation difficulties and loosening.As a result, the patient will require a left knee revision on a future date.No further patient impact reported.No further information available.

• Brand Name: LOGIC TIBIA PS MOD INSRT
• Common Device Name: SEE H10
• 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: katy priest ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16368786
• Report Number: 1038671-2023-00142
• Device Sequence Number: 15301490
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 05/20/2017
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-35-1013
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 05/07/2026
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/12/2023; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female