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

Model Number	PS TIBIAL INSERTS SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical procodes: 200-02-29 - three peg patella 29mm - 1480927; 204-04-32 - trapezoid tibial tray sz 3f/2t - 1322149; 234-03-03 - optetrak asy,ps cemented femoral, sz 3, - 1478627.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 79 yo female patient, initial right knee implanted on (b)(6) 2009, underwent a revision procedure on (b)(6) 2023, approximately 13 years 7 months post the initial procedure.The poly and patella were replaced.Poly issues with flaking and delamination reported.Fragments of polyethylene were present in the knee joint.The surgeon removed the parts/pieces from the patient.There were no surgical delays reported.The patient was last known to be in stable condition following the event.No devices returning as they were discarded by the hospital.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of prosthesis wear that occurred over approximately 13.5 years of use.However, this cannot be confirmed because the components were not returned 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: 16588103
• Report Number: 1038671-2023-00477
• Device Sequence Number: 17568764
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• 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): 05/21/2026

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: 01/07/2017
• Device Model Number: PS TIBIAL INSERTS SZ 3, 9MM
• Device Catalogue Number: 204-23-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 06/23/2023; 04/23/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/26/2023; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2009
• 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-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 176 LB