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

Model Number	LOGIC CR TIB INSERT STD, SZ 2, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 02-010-03-0320 - logic cr femoral cem, right, sz 2 3839415; 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t 4799257; 200-02-35 - three peg patella 35mm 4714422; 201-78-15 - holding pin mini sharp point 4 pk 4593083; 201-78-81 - 3 trocar, mod.Hex 2pk 913520; 521-78-23 - threaded pin size 2.3 collared 5082989; 521-78-23 - threaded pin size 2.3 collared 5082996; 521-78-32 - threaded pin size 3.0 collarless 4977755.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) 2017, underwent a revision procedure on (b)(6) 2023, approximately 5 years 3 months post the initial procedure.The patient was revised due to the poly had delaminated.All implants were removed.The patient was revised to a competitor¿s devices.The patient was last known to be in stable condition following the event.No devices are returning as they were disposed of by the hospital.No further information.
Event or Problem Description
The revision reported was likely the result of presumed prosthesis wear of the tibial insert.However, images of the revised insert and patella components do not show signs of excessive prosthesis wear inconsistent with being implanted for approximately 5.25 years.Malalignment of the components at the time of implantation and/or joint instability cannot be ruled out as possible contributing factors in this case because no radiographs were provided and the revised components were not returned to exactech for evaluation.

• 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: 16539275
• Report Number: 1038671-2023-00433
• Device Sequence Number: 6471772
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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: 06/12/2022
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2, 9MM
• Device Catalogue Number: 02-012-47-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 09/14/2026
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/24/2023; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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: Female