MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2.5, 11MM; SEE H10

Model Number	LOGIC CR TIB INSERT STD, SZ 2.5, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 76 yo female patient, initial left knee implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2023, approximately 2 years 3 months post the initial procedure.The patient returned to the surgeon¿s office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient underwent a poly tibial insert swap and patella implant swap and was reimplanted with a truliant crc tibial insert crc size 2.5, 13mm sn: (b)(6) and an optetrak 3 peg patella cemented 29mm sn: (b)(6).There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No device returns anticipated for analysis.The implant(s) were sent to the lab and legal at the hospital.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 4319957 200-02-29 - three peg patella 29mm.4340659 02-010-03-0225 - logic cr femoral cem, left sz 2.5.4365899 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03104.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The following sections were corrected: b1, b2, d1, g2, h6.The revision reported was likely the result of prosthesis wear.Additionally, the sequence of events as related to the reported wear and instability cannot be confirmed and the contributions of each to the reported event cannot be determined.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 STD, SZ 2.5, 11MM
• Common Device Name: SEE H10
• 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: 17830270
• Report Number: 1038671-2023-02391
• Device Sequence Number: 4450211
• Product Code: JWH
• UDI-Device Identifier: 10885862159151
• UDI-Public: 10885862159151
• 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 Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2020
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2.5, 11MM
• Device Catalogue Number: 02-012-47-2511
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2012
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 175 KG