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

Model Number	LOGIC TIBIA PS MOD INSRT SZ 1 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification, that patient, initial left knee implanted on (b)(6) 2018, with optetrak posterior stabilized tibial insert, along with an optetrak stem, optetrak patella, optetrak screws, a optetrak tibial tray, and a optetrak posterior stabilized femoral component, underwent a revision procedure on (b)(6) 2021, approximately 3 years 1 month post the initial procedure.Plaintiff began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.Plaintiff continues to experience pain and discomfort on a daily basis in her left knee which limits her daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 4769890 02-010-01-0210 - logic femoral ps cem left sz 1.5008184 02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t.5450657 200-02-32 - three peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Additional information received via legal department -revision surgery operative report on (b)(6) 2021.There was a very large effusion of the knee with cloudy yellow fluid, this was collected and sent for fluid culture.The knee was inspected.There was near total catastrophic failure of the polyethylene involving the post and medial compartment with moderate polyethylene loss in the lateral compartment.There was extensive synovitis.There was osteolysis involving the proximal tibia and distal femur.A complete synovectomy was performed for purpose of removal of all polyethylene debris as well as exposure.The femoral component was able to be removed as it was debonded from the cement mantle.The cement was removed and revealed extensive osteolysis involving the medical and lateral femoral condyles and into the distal femoral metaphysis.The tibial component was removed in a similar fashion, and this also had large osteolytic lesion involving the metaphysis.The patella component was inspected and found to be fixed to the patella.A sterile bandage was applied, and the patient was transferred to the recovery room having tolerated the procedure well.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Additional information: a2, a3, b1, b5, b6, b7, & h6 health effect - clinical code & medical device problem code.Pending investigation.
Additional Manufacturer Narrative
H3: investigation results - the revision reported may have been the result of polyethylene wear, osteolysis, and instability as stated in the operative notes.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.Additionally, a contributing factor to the severe wear reported may have been the result of being packaged in a non-conforming vacuum bag for more than five years.

• 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: miguel sosa ; 3523771140
• MDR Report Key: 16363396
• Report Number: 1038671-2023-00136
• Device Sequence Number: 12451788
• Product Code: JWH
• UDI-Device Identifier: 10885862001689
• UDI-Public: 10885862001689
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 01/03/2024

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: 10/12/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 1 9MM
• Device Catalogue Number: 02-012-35-1009
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 02/27/2023; 12/20/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/11/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2010
• 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-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female