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

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 1.5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal / polymer.D10: concomittants: three peg patella 32mm, 200-02-32, logic cr femoral por, right, sz 1.5 02-010-04-0315, (b)(6), lgc tibial fit tray cem sz 1.5f / 0.5t 02-012-45-1505.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a female patient, initial right knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 3 years 11 months post the initial procedure.The revision was due to poly wear.The liner was exchanged.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No patient history, x-rays, or device images were provided.The explanted device is not available for return.The hospital disposed of the device.No further information.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear of the tibial insert.Rotational mismatch between the femoral and tibial components as well as overall posterior slope of the tibial insert may have contributing factors to the wear observed.However, this cannot be confirmed because no radiographs were provided and the revised insert was not returned to exactech for evaluation.Additionally, a contributing factor to the tibial insert wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.

• 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: 17333907
• Report Number: 1038671-2023-01678
• Device Sequence Number: 6608119
• Product Code: JWH
• UDI-Device Identifier: 10885862144409
• UDI-Public: 10885862144409
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 10/12/2023

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: 06/10/2022
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 1.5, 9MM
• Device Catalogue Number: 02-012-51-1509
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female