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

Model Number	LOGIC CR TIB INSERT STD, SZ 1, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial right knee implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2023, approximately 7 years 3 months post the initial procedure due to pain.The bone scan and mri did not show much per the surgeon¿s pa.Poly exchanged.Some wear and possible oxidation were noted on the medial side of the insert.A more constrained 9 crc was implanted.There were no complications.The patient was last known to be in stable condition.Explants not available for return.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer,metal,polymer.Concomitant medical products:¿ (b)(4) 02-010-03-0310 - logic cr femoral cem, right, sz 1, (b)(4) 02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t, (b)(4) 200-02-32 - three peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the reason for the revision in (b)(4) cannot be confirmed from the information provided, but may be due to prosthesis wear as reported, patient conditions, or inclusion of the polyethylene in the packaging recall.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision cannot be confirmed from the information provided, but may be due to prosthesis wear as reported, patient conditions, or inclusion of the polyethylene in the packaging recall.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: kate jacobson ; 3523771140
• MDR Report Key: 16448797
• Report Number: 1038671-2023-00255
• Device Sequence Number: 5835292
• Product Code: JWH
• UDI-Device Identifier: 10885862174130
• UDI-Public: 10885862174130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/06/2025

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: 01/27/2020
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 1, 9MM
• Device Catalogue Number: 02-012-47-1009
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023; 03/05/2025
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/19/2023; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown