MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-41-3535
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6): 02-012-35-3509 - logic tibia ps mod insrt, (b)(6): 02-010-01-0235 - logic femoral ps cem left sz 3.5, (b)(6): 200-02-38 - three peg patella.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01013, 1038671-2026-00422.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear, loosening, and osteolysis.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) loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty on the left side.Subsequently, the patient experienced joint effusion, osteolysis and aseptic loosening.As a result, approximately six years and nine months post-surgery, the patient underwent a revision.It was noted that "the initial impression was that the implants were fixed, but they came off the distal femur & proximal tibia without much effort.This patient had severe osteolysis of the bone.This is particularly wear debris osteolysis because of failure of the medial aspect of the tibial insert that the posterior aspect of the medial portion of the tibial insert was fractured and morselized.The insert, however, remained well fixed.There was no evidence of infection.There was no fracture." patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 3 of 3 for this event/patient.

• Brand Name: LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24875521
• Report Number: 1038671-2026-00423
• Device Sequence Number: 10084413
• Product Code: JWH
• UDI-Device Identifier: 10885862003201
• UDI-Public: 10885862003201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2016
• Device Catalogue Number: 02-012-41-3535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 03/14/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male