MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T; SEE H10

Catalog Number	02-012-41-3030
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	03/07/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient began experiencing pain in hi left knee prosthesis approximately nine months post implant.X-rays from (b)(6) 2013 show lucency around the tibial tray and patient's bone scan showed intense uptake of the tibial component.Patient underwent a revision of his left tibial component with a diagnosis of failed left total arthroplasty secondary to aseptic tibial loosening.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.
Additional Manufacturer Narrative
1038671-2025-00445 multiple mdr reports were filed for this event, please see associated report: 1038671-2025-00445.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1 d4 d10: concomitant devices (b)(6) 200-02-35 - three peg patella 35mm (b)(6) 02-010-01-0230 - logic femoral ps cem left sz 3 g4 h4 h6 (component code, type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, health effect - impact code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of failure of the cement to secure the tibial component to the tibial bone, which led to loosening at the cement-implant interface and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17112003
• Report Number: 1038671-2023-01323
• Device Sequence Number: 19395694
• Product Code: JWH
• UDI-Device Identifier: 10885862003171
• UDI-Public: 10885862003171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2018
• Device Catalogue Number: 02-012-41-3030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown