MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Synovitis (2094)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 4651123 - 2-010-03-0230 - logic cr femoral cem, left, sz 3.02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t.200-02-35 - three peg patella 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a patient, initial knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2024, approximately 7 years post the initial procedure.The surgeon revised the patient due to pain and synovitis.The surgeon noted wear.There were no issues with the surgery.The explanted devices are not available for return.X-rays and a device image were provided.No further information.
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: b, c, d, e, g.The reason for the patient's pain and subsequent revision cannot be confirmed from the provided information but may be due to the inclusion of the implanted polyethylene in the packaging recall.There appear to be isolated pits/damage on the articular surface but no indications of volumetric wear.However, this cannot be confirmed as the devices were not available for evaluation and potential contributions from patient-related considerations could not be assessed from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3, 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18882655
• Report Number: 1038671-2024-00466
• Device Sequence Number: 3037873
• Product Code: JWH
• UDI-Device Identifier: 10885862230409
• UDI-Public: 10885862230409
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 04/15/2025

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 Expiration Date: 01/06/2022
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM
• Device Catalogue Number: 02-012-51-3009
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• 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 Sex: Unknown