MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; SEE H10

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 71 yo female patient, initial right knee implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2024, approximately 2 years 10 months post the initial procedure.The patient was revised due to femoral loosening and poly wear.The femur and liner were revised to a logic ps.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.Device images and x-rays were provided.No device returns for analysis available as the devices were disposed of by the hospital.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: (b)(6)- 02-010-03-0325 - logic cr femoral cem, right, sz 2.5.(b)(6) - 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 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 corrected information.The following sections were updated: g1 - contact email, g3, g6, h1/h2, and h6 - type of investigation, and investigation findings and conclusion.The following sections were corrected: h3, h6 - clinical, medical device problem, and component codes.The revision reported was likely the result of prosthesis wear of the tibial insert and femoral loosening, as stated in the experience report.However, the images of the revised tibial insert do not show signs of extensive wear inconsistent with being implanted for nearly 3 years.The aseptic (non-infected) femoral loosening was likely due to an insufficient bond between the femoral implant and the bone, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.The cause of the prosthesis wear and loosening cannot be determined as there were no details regarding cementing technique or environmental conditions provided and the revised components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK LOGIC
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927361
• Report Number: 1038671-2024-00544
• Device Sequence Number: 17278313
• Product Code: JWH
• UDI-Device Identifier: 10885862230362
• UDI-Public: 10885862230362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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 Model Number: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
• Device Catalogue Number: 02-012-51-2509
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 11/05/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/07/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 90 KG