MAUDE Adverse Event Report: ENOVRE MEDICAL L.P. STAR; REVISION SLIDING CORE STAR ANKLE 11MM

Catalog Number	99-0028-11F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to infection.
Additional Manufacturer Narrative
On (b)(6)2024 independent sales representative, submitted a product feedback form for a revision surgery, stating "potential infection.Previous surgery was performed in 2015 the exact date of previous surgery is not in patient history information.Envois also had not yet acquired the star poly system being revised, so product information was unable to be found." although information about the original implant is unknown, the replacement implant is listed as pn 99-0028/11f ln 2002144.The revision surgery occurred because of a potential infection.The initial surgery occurred approximately 9 years prior to the revision, so it is unlikely the infection was caused by the original implantation of the device.Other aspects of the patient's medical history, such as subsequent surgeries that could have contributed to an infection, remain unknown.It is unknown if the doctor followed the surgical technique during both the original and revision surgeries, so simulated use testing could not occur.The explanted poly was not returned to the houston site, so visual and dimensional inspection did not occur.Due to the limited information available, the root cause shall remain as unknown.

• Brand Name: STAR
• Common Device Name: REVISION SLIDING CORE STAR ANKLE 11MM
• Manufacturer (Section D): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20317642
• Report Number: 1644408-2024-01489
• Device Sequence Number: 7903257
• Product Code: NTG
• UDI-Device Identifier: 00886385026978
• UDI-Public: 00886385026978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 99-0028-11F
• Device Lot Number: 2002144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 62 YR
• Patient Sex: Female