MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	KNEE COMPONENTS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 62 y/o male patient was seen and evaluated by surgeon for right knee pain and swelling on (b)(6) 2023.Patient is s/p r tka in 2014.Radiographs that were taken prior to his office visit revealed asymmetric polyethylene wear to the point that it was a concern that the polyethylene may have worn to the point that the femoral component was articulating with the tibial component and thus a ct was ordered to further evaluate.On exam patient had a severe effusion and pain with regards to the right knee.There were no clinical signs of infection, or a septic knee ct revealed that the polyethylene was not completely worn to metal.Given the rapid wear of the polyethylene, and the patient's symptoms the decision was made to revise the tibial component and replace the polyethylene.Exposure was made through the existing tka scar.When the arthrotomy was made copious amounts of dark straw-colored joint fluid came flowing out.There is no purulence noted in the joint fluid.There is extensive synovitis in the soft tissue superficial to the arthrotomy as well as in the periosteum.In addition to this there were several large size pieces of polyethylene patient the day floating loose within the knee joint.Patient revised r tka with polyethylene exchange.Patient was revised to exactech devices.There was no breakage of the device or surgical delay/prolongation.Sales rep was unable to obtain x-rays or images.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Revision op report- diagnosis: failed tibial insert right knee.There was significant amount of synovitis and an effusion.There was symmetric wear posteriorly on both the medial and lateral aspect of the insert.There was obvious delamination.It was worse medially than laterally.There was no loosening or any osteolysis.There is no evidence of infection, and the joint fluid had a string sign and was also sent out for culture.The patient was then transferred to gurney and taken to the recovery room.No complications.There is no additional information available.
Additional Manufacturer Narrative
Additional manufacturer narrative- additional information added.D10.Concomitants: 3622126, 02-010-03-0335 - logic cr femoral cem, right, sz 3.5; 3723074, 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t; 3777688, 200-02-35 - three peg patella 35mm.Pending investigation.There is no additional information available.
Additional Manufacturer Narrative
H6: corrected medical device clinical code.

• Brand Name: LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: 16916613
• Report Number: 1038671-2023-00979
• Device Sequence Number: 15142671
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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: 02/27/2020
• Device Model Number: KNEE COMPONENTS
• Device Catalogue Number: 02-012-49-3509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/13/2024; 08/19/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/17/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2012
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 90 KG