MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 years and 6 months post the initial right total knee arthroplasty, the patient reported back to the surgeon's office with complaints of stiffness, pain, and dissatisfaction with their right total knee.The patient was revised and underwent a tibial poly implant swap and patella implant swap.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Photos provided show wear of the polyethylene insert.The product is not returning as it was discarded by the hospital.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6), 02-010-03-0350 - logic cr femoral cem, right, sz 5, (b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6), 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4.This follow-up report is being submitted to relay corrected information.The following sections were corrected: d10.D10: 4206683 02-010-03-0350 - logic cr femoral cem, right, sz 5; 4161487 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.
Event or Problem Description
Photos provided show wear of the polyethylene insert and patella.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6.H3: the revision reported was likely the result of tibial insert and patellar prosthesis wear.Possible causes for polyethylene wear include malalignment between the femoral component and the tibial insert, high contract stress during knee flexion, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall with the insert being packaged for over five years prior to implantation, or any combination of these possibilities.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 5, 11MM
• 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: 21200343
• Report Number: 1038671-2025-00324
• Device Sequence Number: 12843504
• Product Code: JWH
• UDI-Device Identifier: 10885862174550
• UDI-Public: 10885862174550
• 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: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-47-5011
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 01/21/2025; 07/23/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/21/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Unknown