MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 1 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 3569072 02-010-01-0210 - logic femoral ps cem left sz 1, 4382600 02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t, 5161787 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 legal notification, that patient, underwent initial left total knee replacement surgery on (b)(6) 2018 and was implanted with an optetrak device.In 2019 and 2020, plaintiff experienced extreme pain and discomfort in her left knee which limited her activities of daily living and her quality of life.Plaintiff underwent revision surgery on her left knee on (b)(6) 2021, approximately 2 years 11 months post initial procedure, and the polyethylene liner and the entire femur and tibial components were revised.Pathology indicated, in part, ¿fibrous tissue with marked foreign-body giant cell reaction".No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
H6.Investigation- 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.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and loosening 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 PS MOD INSRT SZ 1 9MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16461681
• Report Number: 1038671-2023-00310
• Device Sequence Number: 2343513
• Product Code: JWH
• UDI-Device Identifier: 10885862001689
• UDI-Public: 10885862001689
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 12/16/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 1 9MM
• Device Catalogue Number: 02-012-35-1009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 01/07/2025
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/24/2023; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown