MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-010-01-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately 11 years post op the initial tsa, this 78 y/o female patient was revised due to aseptic femoral loosening, femoral component loosening with lateral femoral condyle osteolysis.Patient revised femoral and tibial insert.The case report form indicates this event is possibly related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.Outcome is considered resolved.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-012-35-2009 - logic tibia ps mod insrt sz 2 9mm, (b)(4).Note: cannot determine which insert is left or right.Index surgery was bilateral.Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Manufacturer date: 08/10/11, expiration date: 08/09/19.Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Manufacturer date: 08/10/11, expiration date: 08/09/19.02-010-01-0320 - logic femoral ps cem right sz 2 2132461; 02-012-35-2009 - logic tibia ps mod insrt sz 2 9mm 02-012-45-2010 - lgc tibial fit tray cem sz 2f / 1t 2061405, 2094065; 200-02-32 - three peg patella 32mm 2150093, 2155023; 204-34-02 - fluted stem extension 25l x 14 mm 1899163, 2098463; 204-70-00 - tibial stem ext.Screw 2149170, 2156288.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening over 11 years of implantation secondary to contributions from patient conditions.However, this cannot be confirmed since the devices were not returned for evaluation.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15624743
• Report Number: 1038671-2022-01314
• Device Sequence Number: 15068152
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2026

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 Expiration Date: 01/24/2016
• Device Model Number: 02-010-01-0220
• Device Catalogue Number: 02-010-01-0220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 07/29/2026
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/22/2022; 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2011
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 230 LB
• Patient Race: White