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

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 70 yo male patient, initial left knee implanted in january 2021, returned to the surgeon with pain and swelling.Recent x-rays revealed a significant asymmetry between the image taken on the right side in 2021 and the one taken on the left side last week.Currently, the patient is on the waiting list for a revision and is hopeful that only the insert will need to be replaced.The surgeon, following two issues of the same nature occurring in a short period, wants to investigate the causes leading to the premature wear of the polyethylene.X-rays were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: (b)(4) - 02-010-01-0235 - logic femoral ps cem left sz 3.5 (b)(4) - 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t (b)(4) - 200-02-35 - three peg patella 35mm (b)(4) - a10012 - gps implant kit v2 additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Further review determined this case is a duplicate case and the event has been reported under mdr#1038671-2024-01487.

• Brand Name: 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: 18735780
• Report Number: 1038671-2024-00260
• Device Sequence Number: 20402218
• Product Code: JWH
• UDI-Device Identifier: 10885862173591
• UDI-Public: 10885862173591
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 09/06/2024

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 Expiration Date: 06/20/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
• Device Catalogue Number: 02-012-44-3509
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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 Age: 70 YR
• Patient Sex: Male