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

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that patient, initial left knee implanted on (b)(6) 2013, with an optetrak logic psc polyethylene tibial insert, underwent a revision surgery on (b)(6) 2022, approximately 3 years 11 months post the initial procedure to remove the failed polyethylene liner.Upon information and belief, the plaintiff¿s left knee revision surgery was due to accelerated and preventable wear of the defective polyethylene insert component within the optetrak device.As a direct, proximate, and legal consequence of the defective nature of the optetrak device as described herein, the plaintiff has suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries which all require ongoing medical care.No device returns anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of polyethylene wear of the tibial insert.The extent and root cause of the prosthesis wear cannot be determined as the device(s) were not available for evaluation and images of the explanted device(s)/pre-revision radiographs were not provided.

• 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: 16457449
• Report Number: 1038671-2023-00275
• Device Sequence Number: 6572571
• Product Code: JWH
• UDI-Device Identifier: 10885862173409
• UDI-Public: 10885862173409
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 12/21/2019
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM
• Device Catalogue Number: 02-012-44-1011
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown