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

Model Number	PS TIBIAL INSERTS SZ 2, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification, that patient, underwent initial revision of her failed right optetrak device on (b)(6) 2015.Upon explantation of the optetrak device, plaintiff¿s surgeon observed that the tibial component was loose and showed gross motion.In the years following the revision surgery, plaintiff once again experienced pain, swelling, instability, and bone loss in her right knee caused by early and accelerated polyethylene wear and/or component loosening.The pain and instability in plaintiff's right knee continued to become more severe, and it became necessary to undergo a second right knee revision surgery, which was performed on (b)(6) 2019, approximately 3 years 2 months post revision procedure.Plaintiff¿s clinical, laboratory, and radiological workup on her right knee were negative for infection, but positive for loosening secondary to osteolysis secondary to polyethylene wear.During the second revision surgery, it was noted that both the femoral and tibial components were loose and removed with minimal effort.Upon explantation of the optetrak device, the surgeon observed ¿significant wear in the medial aspect and around the posterior post¿ of the tibial insert.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: (b)(4), 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t.(b)(4), 204-36-08 - stem extension 80l x16 mm.(b)(4), 204-70-00 - tibial stem ext.Screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Upon investigation, it was discovered that this report is a duplicate mfr# 1038671-2019-00421, (b)(4): concomitant components cited as product info.Additional/new information will be captured in (b)(4) and reported under mfr# 1038671-2019-00421.

• Brand Name: OPTETRAK
• 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: 16460776
• Report Number: 1038671-2023-00297
• Device Sequence Number: 20461658
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 07/19/2023

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: 04/13/2018
• Device Model Number: PS TIBIAL INSERTS SZ 2, 13MM
• Device Catalogue Number: 204-22-13
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown