MAUDE Adverse Event Report: Exactech, Inc. LOGIC FEMORAL PS CEM LEFT SZ 3.5; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	02-010-01-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Periprosthetic fracture (4902)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.It was reported this patient underwent a left total knee arthroplasty.Subsequently, four (4) years, nine (9) months later, the patient was revised to a competitor's construct due to prosthesis wear of the polyethylene component and loosening of the femoral component.A revision operative report was provided.Intraoperatively, the patella component was noted to be well fixed.The femoral component was easily removed without much bone loss.Osteolysis was observed in the tibia.After trialing new components, an anterior cortical fracture was observed.This required 2 cables to be placed.After this there is no fracture gapping.The patient was revised to a competitor's construct.The patient was awoken from anesthesia and transferred to the recovery room in stable condition.Additionally, it is reported via legal documentation, the patient has and continues to experience pain and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, bone loss and other injuries presently undiagnosed.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 3.5
• 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 66 court; gainesville, FL 32653
• MDR Report Key: 50063037
• Report Number: 1038671-2026-00955
• Device Sequence Number: 10731216
• Product Code: JWH
• UDI-Device Identifier: 10885862001153
• UDI-Public: 10885862001153
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2021
• Device Catalogue Number: 02-010-01-0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2016
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male