MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
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	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 65 yo male, initial right knee implanted on (b)(6), 2018, underwent a revision procedure on (b)(6), 2022, approximately 5 years 4 months post the initial procedure.Reason for revision not reported.Poly swap indicated.No device breakage or surgical delays reported.The patient was last known to be in stable condition following the event.No x-rays or device images were able to be obtained.No device returns available as the hospital kept the device.No further information.Patient was revised to exactech devices.(b)(6), 02-012-48-4009 - logic cr tib insert slope+, sz 4, 9mm; serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k111400.Concomitants: (b)(6), 02-010-03-0340 - logic cr femoral cem, right, sz 4; (b)(6), 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t; (b)(6), 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: (b)(6), 02-010-03-0340 - logic cr femoral cem, right, sz 4; (b)(6), 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t; (b)(6), 200-02-35 - three peg patella 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6 mdr section codes updated/corrected: a, b, c, d, g the reason for the reported revision cannot be confirmed from the information provided but may be due to wear, loosening, infection, fracture, instability, and/or patient related factors.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information, images, or radiographs were not provided.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 SLOPE+, SZ 4, 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17587661
• Report Number: 1038671-2023-02000
• Device Sequence Number: 6504738
• Product Code: JWH
• UDI-Device Identifier: 10885862174482
• UDI-Public: 10885862174482
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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): 07/18/2025

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: 05/09/2021
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
• Device Catalogue Number: 02-012-48-4009
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male