MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-1009
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices unknown.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 75 months after a left total knee replacement procedure, the patient underwent a revision procedure for unknown issues.The device was not returned for evaluation.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.No further issues or complications were reported.No additional information is available.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
Information regarding the reason for the revision was not provided.Due to the limited information, this complaint event cannot be further investigated or confirmed, and a definitive cause, in addition to any potential product, patient, and/or user-related contributing factors cannot be definitively determined.There is no indication within the available information that a new or unexpected failure mode or harm/adverse event type has occurred or that the benefit-risk analysis for these products has been altered; therefore, no further risk analysis will be performed.However, this event will be included in complaint trending and actions will be taken as required upon detection of any trend signals.No further action or escalation will be taken at this time concerning this reported event.Should additional relevant information be received concerning this event, the complaint investigation will be re-opened and actions will be taken as appropriate.

• Brand Name: LOGIC CC TIB INSERT SIZE 1, 9MM
• 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: 19833175
• Report Number: 1038671-2024-02543
• Device Sequence Number: 12617685
• Product Code: JWH
• UDI-Device Identifier: 10885862265746
• UDI-Public: 10885862265746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 10/15/2023
• Device Catalogue Number: 02-012-65-1009
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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; Hospitalization
• Patient Sex: Unknown