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

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately twelve years post initial bilateral tka, patient left knee was revised due to pain.Components were well fixed.The insert was found to have an unusually metal piece imbedded into the top layer.It appeared that the metal caps on the tibial baseplate that cover the hole for possible augments were potentially never captured under the insert during the initial procedure.Patient chose a different company for the revision with surgeon discussion.Explants not available.Patient left in stable condition.No further information.
Additional Manufacturer Narrative
Concomitant products: logic femoral ps cem left sz 3.5 (cat# 02-010-01-0235 / serial# (b)(4)); three peg patella 38mm (cat# 200-02-38 / serial# (b)(4)); logic tibia traptray cem sz 3.5f/3.5t (cat# 02-012-41-3535 / serial# (b)(4); 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, d8, g1, h4, h6.Mdr section codes updated/corrected: a, b, c, d, g.The revision reported was likely the result of prosthesis wear, which may have led to pain.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, excessive posterior slope, third body wear, patient-related conditions, instability, or any combination of these possibilities.Because the components were implanted for over 11 years, it is unclear when or how the screw hole cover detached from the tibial tray.The contributions of prosthesis wear and disassembly of the screw hole cover to the sequence of events cannot be determined as the devices were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/3.5T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16490077
• Report Number: 1038671-2023-00362
• Device Sequence Number: 17617286
• Product Code: JWH
• UDI-Device Identifier: 10885862003201
• UDI-Public: 10885862003201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2016
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2011
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11-4132 STRYKER SYS 6 90X13/21X1.19.; ACCELERATE CONC. SYS REP BY 620-12-02.; PLATELET RICH PLASMA KIT WITH SPRAY TIPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown