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

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 2.5
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: femoral stem, tibial insert 02-012-44-2511, tibial tray 02-012-45-2515, tibial stem extension 204-34-02, patellar 200-02-32.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via an exactech clinical knee replacement study, that a 68 yo female, initial implant date, (b)(6) 2014, was revised on (b)(6) 2017, approximately 3 years 6 months post the initial procedure due to aseptic femoral loosening.The femoral component and the tibial insert were revised.The study indicates the event was unlikely related to the device and definitely related to the procedure.The event required inpatient hospitalization.The outcome indicates resolved on (b)(6) 2018.No device returns anticipated due to study guidelines.No further information.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the revision reported was likely the result of an insufficient bond between the femoral component and the bone and patient-related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were unable to be obtained.

• 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 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16244089
• Report Number: 1038671-2023-00071
• Device Sequence Number: 6409025
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 2.5
• Device Catalogue Number: 02-010-01-0225
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 04/22/2026
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/14/2023; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 236 LB
• Patient Race: White