MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3511
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 02-010-03-0235 logic cr femoral cem, left, sz 3.5, 02-012-45-3535 lgc tibial fit tray cem sz 3.5f / 3.5t.
Event or Problem Description
As reported, the patient had a primary left total knee arthroplasty (tka) in 2015.The patient presented back with complaints of pain, swelling, and dissatisfaction with their tka.After examination, the patient was scheduled for revision surgery.The patient underwent a polyethylene implant exchange.There were free-floating pieces of polyethylene floating in the knee joint and attached to the soft tissue once opening up the capsule of the knee joint.The pieces were removed along with the poly implant.The knee joint was irrigated well.The patient was last known to be in stable condition after surgery.
Additional Manufacturer Narrative
The revision reported was likely the result of instability due to malposition or imbalance of the knee.The tibial insert exhibits signs of mechanical overload on the posterior medial edge of the tibial insert leading to damage and delamination of the polyethylene, in which bmi may have been an additional factor.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.However, the reported instability could not be confirmed clinically from the provided information.Potential contributions of user and patient-related considerations to the event outside of bmi could not be assessed as the devices were not available for evaluation and relevant clinical information were not provided.This follow-up report is being submitted to relay additional information.The following sections were updated: d4 serial number.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code and problem code.
Additional Manufacturer Narrative
The revision reported was likely the result of instability due to malposition or imbalance of the knee.The tibial insert exhibits signs of mechanical overload on the posterior medial edge of the tibial insert leading to damage and delamination of the polyethylene, in which bmi may have been an additional factor.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.However, the reported instability could not be confirmed clinically from the provided information.Potential contributions of user and patient-related considerations to the event outside of bmi could not be assessed as the devices were not available for evaluation and relevant clinical information were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
• 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: 20660059
• Report Number: 1038671-2024-04349
• Device Sequence Number: 12584284
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 08/11/2019
• Device Catalogue Number: 02-012-49-3511
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 04/08/2025; 04/09/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 04/09/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2011
• 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: 76 YR
• Patient Sex: Female