MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 2989540 - 02-010-03-0335 - logic cr femoral cem, right, sz 3.5 2155618 - 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t 3946440 - 200-02-29 - three peg patella 29mm.H7: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2015.The patient presented back to the surgeon's office with complaints of their total knee.The polyethylene insert is a recalled liner showing wear on imaging.The patient was scheduled for a knee revision and possible poly exchange on (b)(6) 2023.The patient underwent a tibial poly 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.
Additional Manufacturer Narrative
User-related considerations: there were no user-related issues reported that appear to have contributed to the reported event.Patient-related considerations: there are no patient conditions reported that appear to have contributed to the reported event.The reason for the revision reported cannot be confirmed from the information provided but may be due to the inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event 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.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code and component code.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3.5, 9 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18334964
• Report Number: 1038671-2023-02995
• Device Sequence Number: 6711982
• Product Code: JWH
• UDI-Device Identifier: 10885862159243
• UDI-Public: 10885862159243
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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 Expiration Date: 11/05/2020
• Device Catalogue Number: 02-012-47-3509
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female