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

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Unspecified Tissue Injury (4559)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification, that a male patient, who had an initial right total knee replacement on (b)(6), 2013, and was implanted with optetrak logic devices, underwent a revision procedure on (b)(6), 2019, approximately 6 years post the initial procedure.Following a period of post-implantation recovery, and for years after the replacement surgery, the patient¿s knee device performed as expected.The patient underwent revision of the right knee devices, secondary to complete polyethylene liner wear resulting in aseptic loosening with massive soft tissue damage and osteolysis requiring significant bone grafting and augmented revision components.Additionally, the legal brief indicates that despite undergoing the revision surgeries, the patient experiences daily knee pain and discomfort which limit their activities of daily living and recreation and impacts their quality of life.The patient 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; metallosis; soft tissue damage; infection; and other injuries presently undiagnosed, which all require ongoing medical care.The patient has sustained and will sustain future damages, including but not limited to additional revision surgeries; cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress; and pain and suffering.No device returns anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patello femoral, semi-constrained, cemented, polymer/metal/polymer concomitant medical products: (b)(4) 02-010-03-0340 - logic cr femoral cem, right, sz 4; (b)(4) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(4) 200-02-38 - three peg patella 38mm additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported may have been the result of loosening, osteolysis, and polyethylene wear as stated in the legal documentation.The aseptic (non-infected) loosening may have been the result of both patient-related conditions and an insufficient bond between the implant and the bone.The extent and root cause of the reported polyethylene wear and osteolysis cannot be confirmed as the device(s) were not returned for evaluation and pre-revision radiographs, photographs, and operative notes were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, h3, h6 - health effect - clinical code, component code, type of investigation, investigation findings, h7 and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK 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 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16628321
• Report Number: 1038671-2023-00522
• Device Sequence Number: 11868838
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 11/01/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM
• Device Catalogue Number: 02-012-49-4009
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 07/28/2023; 04/14/2026
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 10/19/2023; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male