MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 3, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the surgeon removed all implants from the 61 y/o female patient and replaced them with competitor's devices.The surgeon refused to have any sales rep attended the case.Therefore, reason of revision is unknown.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation as they were disposed by the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products: logic cr femoral por, right, sz 3 (cat#: 02-010-04-0330 / serial#: (b)(6).Lgc tibial fit tray cem sz 3f / 3t (cat#: 02-012-45-3030 / serial#: (b)(6).Three peg patella 35mm (cat#: 200-02-35 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the top five reasons for total knee arthroplasty account for approximately (b)(4) of the reasons that drive revision/surgical intervention.The failure mechanisms are as follows: 39.9% for loosening; 2(b)(4) for infection; 7(b)(4) for instability; (b)(4) for periprosthetic fracture; and (b)(4) for arthrofibrosis.In early revisions (less than two years) infection was found to be the most common failure mechanism and late revisions show aseptic loosening as the most common reason.(1) 1.Sharkey, p.L.(2014s, september).Why are total knee arthroplasties failing today¿has anything changed after 10 years? the journal of arthroplasty, 29.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the revision cannot be conclusively determined.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the revision cannot be conclusively determined.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson
• MDR Report Key: 18121689
• Report Number: 1038671-2023-02758
• Device Sequence Number: 7015960
• Product Code: JWH
• UDI-Device Identifier: 10885862174345
• UDI-Public: 10885862174345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 04/23/2025

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: 12/09/2025
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3, 9MM
• Device Catalogue Number: 02-012-47-3009
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 08/19/2024; 04/23/2025
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 08/23/2024; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female