MAUDE Adverse Event Report: OVERTURE ORTHOPAEDICS OVERTURETI KNEE RESURFACING SYSTEM - FEMORAL IMPLANT; KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS

Catalog Number	PKG-90-OVR-102240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 overture was informed that a patient experienced acute infection of the surgical site and a overtureti removal tray kit was requested.The overtureti knee resurfacing system -femoral implant was implanted on (b)(6) 2024, and removal of implant was completed on (b)(6) 2024.On may 28, 2024, further information was provided indicating that during the removal the infection area was cleaned, and patient is doing well with high white blood cell count confirmed.No further information has been provided to date.

• Brand Name: OVERTURETI KNEE RESURFACING SYSTEM - FEMORAL IMPLANT
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): OVERTURE ORTHOPAEDICS; 5 peters canyon road; suite 160; irvine CA 92606
• Manufacturer Contact: tamala wampler ; 5 peters canyon road; suite 160; irvine, CA 92606
• MDR Report Key: 19533479
• Report Number: 3027737826-2024-00001
• Device Sequence Number: 6081089
• Product Code: HSX
• UDI-Device Identifier: 00810129550092
• UDI-Public: 01008101295500921728083110LSP002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PKG-90-OVR-102240
• Device Lot Number: LSP0022
• 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: 05/14/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown