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

Catalog Number	02-010-01-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Joint Laxity (4526)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 91 months after a left total knee replacement procedure, the patient has experienced prosthesis wear and joint laxity.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted aseptic loosening cemented left knee prosthesis and polyethylene wear/failure.Intraoperative findings noted synovitis with pe particles.Significantly loose cemented ps femoral component.Subsided cemented tibial component.Worn pe patella component-well fixed.Medial cavitary distal femoral bone loss was noted.No significant tibial or patella bone loss was encountered.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (2886092) 02-012-35-2009 - logic tibia ps mod insrt sz 2 9mm;p (4010919) 200-02-32 - three peg patella 32mm; (3933347) 02-012-41-2020 - logic tibia traptray cem sz 2f/2t.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
The revision reported may have been the result of prosthesis wear, femoral loosening, and tibial tray subsidence as stated in the operative notes.The prosthesis wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions.The tibial tray subsidence may have been the result of poor bone quality, misalignment, a load transfer issue, or any combination of these possibilities.However, the reason for the reported prosthesis wear, femoral loosening, and tibial tray subsidence could not be confirmed as the devices were not returned for evaluation, and images/radiographs were unable to be obtained.H6: corrected investigation clinical codes.

• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21506430
• Report Number: 1038671-2025-01363
• Device Sequence Number: 19981120
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• 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: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 04/20/2020
• Device Catalogue Number: 02-010-01-0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 04/23/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female