MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee revision on (b)(6) 2015.Approximately 3 years and 6 months after the first right knee revision the patient had a second right knee revision on (b)(6) 2019.During the (b)(6) 2019, revision surgery, the surgeon found that the polyethylene failed, had an excessive amount of wear, and was degrading/shedding polyethylene debris that caused metallosis, pain, swelling, osteolysis, synovitis, bone loss, and tissue damage.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
D10: concomitants: 2319334 02-012-42-2008 - logic pts, size 2, 8mm 3718740 204-36-08 - stem extension 80l x16 mm 3795675 204-70-00 - tibial stem ext.Screw 3861530 02-012-45-2030 - lgc tibial fit tray cem sz pending investigation.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 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: michael crader ; 3523771140
• MDR Report Key: 17555392
• Report Number: 1038671-2023-01959
• Device Sequence Number: 4801861
• Product Code: JWH
• UDI-Device Identifier: 10885862174338
• UDI-Public: 10885862174338
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2024

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: 03/07/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM
• Device Catalogue Number: 02-012-49-2013
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 02/22/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 01/25/2024; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown