MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-01085 d10: concomitant devices: (b)(6), 02-012-35-4013 - logic tibia ps mod insrt sz 4 13mm, (b)(6), 200-02-35 - three peg patella 35mm, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t, (b)(6), 204-34-04 - fluted stem extension 40l x 14 mm.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.
Event or Problem Description
As reported via legal documentation a 61 y/o male patient had a right knee replacement on (b)(6) 2017.Approximately 5 years and 9 months after the initial procedure the patient had a right knee revision on (b)(6) 2022 due to a failed right knee arthroplasty.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.Revision op report rec'd 21 apr 2023.There was found to be clear synovial joint fluid.There was found to be visible polyethylene wear within the tibial polyethylene.There was a grossly loose femoral component from the cement mantle.There was a severe synovial reaction and complete synovectomy was performed.There was a partially fixed tibial component.There was moderate osteolysis around the cement of the femoral component and moderate osteolysis at the proximal tibia.The patient was awakened and transferred to the recovery room in stable condition.No complications.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 4
• 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 ct; gainesville, FL 32653
• MDR Report Key: 21022539
• Report Number: 1038671-2024-05009
• Device Sequence Number: 4008774
• Product Code: JWH
• UDI-Device Identifier: 10885862001252
• UDI-Public: 10885862001252
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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: 09/29/2021
• Device Catalogue Number: 02-010-01-0340
• 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: 04/21/2023
• Initial Report FDA Received Date: 12/26/2024
• Date Device Manufactured: 09/30/2016
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male