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

Model Number	LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer concomitants medical product: (b)(4), 02-010-03-0335, logic cr femoral cem, right, sz 3.5.(b)(4), 200-02-32, three peg patella 32mm.(b)(4), 02-012-45-3535, lgc tibial fit tray cem sz 3.5f / 3.5t.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that patient, underwent initial right total knee replacement surgery on (b)(6) 2018, and was implanted with an optetrak device, including an optetrak logic tibial insert, size 3.5, 9mm made of polyethylene.Plaintiff underwent revision surgery of his right knee on (b)(6) 2022, approximately 4 years post initial procedure.Upon information and belief, the loose components and osteolysis in plaintiff's right knee was due to premature polyethylene wear of the tibial insert.Following revision surgery, plaintiff continues to be limited in his activities of daily living.Despite undergoing revision surgery, plaintiff experiences daily pain and discomfort in his left knee which limits his activities of daily living and impacts his quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
G4, h3: the revision reported in the case may have been the result of polyethylene wear and osteolysis as stated in the legal documentation.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the explanted device was not returned for evaluation, and radiographs, photographs, and operative notes were provided.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16433780
• Report Number: 1038671-2023-00217
• Device Sequence Number: 7401150
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 09/11/2023

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: 07/20/2024
• Device Model Number: LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-48-3509
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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