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

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.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 patient, initial total left knee replacement surgery on (b)(6) 2012 and was implanted with an exactech knee system.In the ensuing time, plaintiff began to suffer from symptoms associated with the defects of exactech knee system as alleged in this complaint, including pain and lack of mobility.As a result of these symptoms, plaintiff underwent revision surgery on (b)(6) 2017, approximately 5 years post the initial procedure.The clinical findings and diagnoses as a result of the revision surgery are consistent with the defects of the exactech knee system, as alleged in this complaint.Plaintiff experiences, pain, lack of mobility and enduring limitations on activities of daily living, quality of life, and ability to perform work functions.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.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 patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.H7.H9.The device identification is unknown, it was not reported.
Additional Manufacturer Narrative
D10: (b)(6) 02-010-01-0225 - logic femoral ps cem left sz 2.5.(b)(6) 02-012-41-2525 - logic tibia traptray cem sz 2.5f/2.5t.(b)(6) 200-02-32 - three peg patella 32mm.
Event or Problem Description
It was reported via legal documentation that approximately 60 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening, pain, and lack of mobility.Revision surgery operative notes were provided and indicate findings of synovitis, bone loss with erosion on femur and tibia and loose femoral component.No further issues or complications 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 reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral 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 PS MOD INSRT 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: 16371777
• Report Number: 1038671-2023-00146
• Device Sequence Number: 6757641
• Product Code: JWH
• UDI-Device Identifier: 10885862001788
• UDI-Public: 10885862001788
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-35-2513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/21/2023; Not provided; 01/07/2025
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/21/2023; 12/09/2024; 01/08/2025
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UNK
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Unknown