MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 9 MM

Model Number	02-012-49-1509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 2 years and 8 months postop the initial implant, the (b)(6) y/o female patient, previously treated for right knee windswept deformity, had severe right knee pain, then a patellofemoral arthrosis was suspected by the x-ray findings.The surgeon prefers the surgical philosophy without resurfacing patella for primary knee replacement surgery and he has excellent long-term clinical results for this philosophy, however, he planned to resurface the patella using our patella component for this case.When the knee was exposed, abnormal proliferative synovium was seen around the knee, and remarkable polyethylene wear of the tibial insert was also found at the antero-lateral part of the insert.Then he removed the insert to check the condition of posterior aspect of the knee, he confirmed that poster-medical part of the insert was severely damaged by delamination wear.As he was concerned about using same type to the sloped insert, he performed trial reduction using the neutral insert of 9 mm thickness and decided to use it for this replacement.He also added v-shape arthrotomy to address the joint stiffness in flexion.The surgery was finished inserting the neutral insert and resurfacing patella to patellar component without any troubles.Patient was last known to be in stable condition following the event.Devices were not retrieved from the facility.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision was likely the result of a combination of axial rotation mismatch of the femoral component relative to the tibial insert, and the overall posterior slope of the tibial insert, which allowed for excessive posterior contact, especially medially, leading to wear of the polyethylene.No information provided in the following section(s): a4, a5, and b6, the following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 9 MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10177026
• Report Number: 1038671-2020-00315
• Device Sequence Number: 16721784
• Product Code: JWH
• UDI-Device Identifier: 10885862144409
• UDI-Public: 10885862144409
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 01/09/2025
• Device Model Number: 02-012-49-1509
• Device Catalogue Number: 02-012-49-1509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR