MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-4011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: unknown date in 2014.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.
Event or Problem Description
It was reported that the patient underwent an initial right knee replacement on an unknown date.Subsequently, the patient experienced pain, stiffness and dissatisfaction with their knee replacement.As a result, the patient underwent a right knee revision surgery, approximately 9 years after initial surgery, where the polyethylene insert was exchanged.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not available for evaluation, and relevant patient information or images were not provided.No conclusions can be made from the provided radiograph.An additional contributing factor to the revision may have been inclusion of the polyethylene in the packaging recall.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22022612
• Report Number: 1038671-2025-02065
• Device Sequence Number: 9412008
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• 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 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
• Report Date (Section B): 10/15/2025

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: 02-012-49-4011
• 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: 05/11/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Female