MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, LEFT, SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately seven years post initial left tka, the 68 y/o female patient was revised due to osteolysis and polyethylene wear.The patient experienced synovitis and implant pain.All the implants were removed and revised in to competitor¿s products.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays attached.The devices are not available for evaluation due to they were disposed at the hospital.No additional information is available.
Additional Manufacturer Narrative
Report number: 1038671-2024-00272 d10 concomitant products: three peg patella 35mm (cat# 200-02-35 / seral# (b)(6)).Femoral component cr, porous size 3.5, l (cat# 02-010-04-0235 / serial# (b)(6)).Fit tibial tray cemented size 3.5f/2.5t (cat# 02-012-45-3525 / serial# (b)(6)).E1: phone number: (b)(6).G4: 510k k140302, k123687.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-0027.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, osteolysis, and/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 relevant clinical information 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 CR FEMORAL POR, LEFT, SZ 3.5
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 20907991
• Report Number: 1038671-2024-04779
• Device Sequence Number: 4008074
• Product Code: JWH
• UDI-Device Identifier: 10885862158260
• UDI-Public: 10885862158260
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140302,
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2021
• Device Catalogue Number: 02-010-04-0235
• 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: 01/30/2024
• Initial Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 03/10/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 88 KG