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 Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 48 months after a left total knee replacement procedure, the patient underwent a revision procedure to address.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6), 02-010-03-0235 - logic cr femoral cem, left, sz 3.5.(b)(6), 200-02-32 - three peg patella 32mm.(b)(6), 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t.The device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report 1038671-2023-00126.

• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19310733
• Report Number: 1038671-2024-01234
• Device Sequence Number: 6911153
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 03/06/2021
• Device Catalogue Number: 02-012-49-3511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2013
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown