MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/27/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 2516752 02-010-01-0235 - logic femoral ps cem left sz 3.5.2935884 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.2956579 200-02-35 - three peg patella 35mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2014.This has not yet been explanted.Patient began experiencing significant pain, swelling and popping.On (b)(6) 2022 the patient reported swelling after daily activities.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
H6: corrected health effect clinical code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear, instability, and loosening and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17361732
• Report Number: 1038671-2023-01718
• Device Sequence Number: 6068735
• Product Code: JWH
• UDI-Device Identifier: 10885862001863
• UDI-Public: 10885862001863
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 01/13/2019
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM
• Device Catalogue Number: 02-012-35-3513
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown