MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-4009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t (b)(6) 02-010-03-0240 - logic cr femoral cem, left, sz 4 (b)(6) 200-05-26 - inset patella 26mm (b)(6).
Event or Problem Description
As reported, approximately 6 years and 7 months post the initial left total knee arthroplasty (tka), the patient presented to the surgeon's office complaining about their left knee.The patient reported pain, instability and dissatisfaction.The patient has a recalled poly insert.The x-ray shows osteolysis.The patient underwent revision surgery and the femoral component and poly were revised.The patient was revised to femoral cc revision component and psc poly implant.The surgeon wanted to upsize the femur component knowing that it is off-label if keeping the current tibia implant.The tibia component was well fixed and the surgeon trialed a psc poly implant for that size tibia.The surgeon was happy with the articulation and stability.The patient was implanted with the revision components and left the or stable.There was no reported breakage of a device or surgical delay/prolongation.Related report: 1038671-2024-03848.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3, h6 type of investigation, investigation findings, investigation conclusions.The following sections were corrected: h6 clinical code.H3: the revision reported was likely the result of prosthesis wear.Potential causes of the polyethylene wear may be related to inclusion of the polyethylene in the packaging recall, high contact stress to the knee in flexion, the alleged joint instability, patient-related issues, or any combination of the listed factors.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20416158
• Report Number: 1038671-2024-03909
• Device Sequence Number: 20885375
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• 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: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 05/09/2021
• Device Catalogue Number: 02-012-49-4009
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male