MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 4F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-41-4030
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via information received by the legal department that this patient had a left total knee arthroplasty on (b)(6) 2016 and then approximately 5 years, 3 months, she had the left knee revision surgery on (b)(6) 2021.Revision operative report of (b)(6) 2021.Left total knee arthroplasty aseptic loosening.Patient presented with painful left knee and found to have clear loosening of the tibial component radiographically as well as instability.Procedure: patella found to be intact.The femoral component was found to be well fixed.Bony inventory after removal of the femoral component revealed aori 3b defects secondary to osteolysis.The tibial component was found to be grossly loose and easily tamped out.Bony inventory after removal of cement revealed aori 2b defects, worse laterally affecting the metaphysis.Tibial bone loss called for use of a size b cone.During procedure with a competitor¿s device there was a bone fracture.Dressings were applied and the patient was transferred to the recovery room in stable condition.Discharge to home when comfortable and pt goals are met.Hospital care: admission (b)(6) 2021, discharge (b)(6) 2021.There is no other patient demographic or medical history available.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.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.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 4F/3T
• 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 32563
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 16992952
• Report Number: 1038671-2023-01108
• Device Sequence Number: 6993594
• Product Code: JWH
• UDI-Device Identifier: 10885862003225
• UDI-Public: 10885862003225
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2025

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: 11/10/2020
• Device Catalogue Number: 02-012-41-4030
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 01/07/2025; 02/11/2025
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 01/07/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown