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

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: serial #: (b)(4), category #: 200-02-29 - three peg patella 29mm.Serial #: (b)(4), category #: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.Serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw.Serial #: (b)(4), category #: 02-010-01-0330 - logic femoral ps cem right sz 3.Serial #: (b)(4), category #: 204-34-02 - fluted stem extension 25l x 14 mm.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 a patient, initial left knee implanted with an optetrak insert made of polyethylene on (b)(6) 2015, underwent a revision procedure on (b)(6) 2021, approximately 5 years 5 months post the initial procedure.As a result of defendants¿ failure to properly package the optetrak device prior to distribution, the polyethylene liner prematurely degraded and the plaintiff was required to undergo revision surgery due to severe pain, swelling, and instability in the knee and leg.These injuries were caused by early and preventable wear of the polyethylene insert and resulting component loosening and/or other failures causing serious complications including tissue damage, osteolysis, permanent bone loss and other injuries.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 presently undiagnosed, which all require ongoing medical care.As a further direct, proximate and legal consequence of the defective nature of the optetrak device, the plaintiff has sustained and will sustain future damages, including but not limited to cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress and pain and suffering.
Additional Manufacturer Narrative
Additional information- upon investigation this complaint was found to be a duplicate, all information including investigation results were appropriately reported under mfr# 1038671-2021-00091.

• 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: 16584861
• Report Number: 1038671-2023-00437
• Device Sequence Number: 1688311
• Product Code: JWH
• UDI-Device Identifier: 10885862173584
• UDI-Public: 10885862173584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 01/03/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
• Device Catalogue Number: 02-012-44-3015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2012
• 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