MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577); Insufficient Information (4580); Joint effusion (4849)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomittants: 4891046 02-012-41-2525 - logic tibia traptray cem sz 2.5f/2.5t.6001228 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5.6038791 200-02-35 - three peg patella 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that a patient, initial left total knee replacement, implanted with a truliant device on (b)(6) 2019, underwent a revision procedure on (b)(6) 2022, approximately 2 years 6 months post the initial procedure, for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.The plaintiff experiences daily pain and discomfort in her left knee which limits her activities of daily living and impacts her quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: b1, b2, b3, d6b, g3, h6; clinical codes, medical problem code, component code additional information: a2, a3, b5, d10, g, g2, h6 investigation codes d10: serial #: (b)(6), category #: 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5, serial #: (b)(6), category #: 02-012-41-2525 - logic tibia traptray cem sz 2.5f/2.5t, serial #: (b)(6), category #: 200-02-35 - three peg patella 35mm.
Event or Problem Description
It was reported that approximately 31 months after a left total knee replacement procedure, the patient underwent a left knee revision surgery to address discomfort, swelling and synovial effusion.A post operative report was provided.Post operative diagnosis noted failed left total knee replacement secondary to polyethylene wear.Intraoperatively the surgeon observed hypertrophic synovial reaction and synovitis.The femoral component was noted to be well fixed with no evidence of loosening.The polyethylene tibial component was then removed and noted to have significant wear delamination of the medial aspect.The patella component was noted as not significantly worn and in good shape.The tibial insert was replaced.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: a, b, c, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 IMPLANT PSC INSERT, SZ 2.5, 13MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16454100
• Report Number: 1038671-2023-00267
• Device Sequence Number: 14917884
• Product Code: JWH
• UDI-Device Identifier: 10885862173539
• UDI-Public: 10885862173539
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/06/2025

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: 12/14/2019
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM
• Device Catalogue Number: 02-012-44-2513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 05/08/2023; 02/06/2024; 05/05/2025
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/12/2023; 05/16/2023; 02/19/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2011
• 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: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Unknown