MAUDE Adverse Event Report: ENOVRE MEDICAL L.P. STAR; SLIDING CORE, UHMPWE,7MM

Catalog Number	400-141F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/03/2024
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 ankle pain.
Additional Manufacturer Narrative
See h6, h11.On 09/03/2024, independent sales representative, submitted a salesforce form describing a star ankle revision surgery.The case took place on (b)(6) 2024 at swedish medical center, with original implantation occurring on (b)(6) 2015.The form lists the cause of event as, "patient revised due to ankle pain." the revision surgery occurred due to patient pain, during which the original 7mm poly implant pn 400-141f was replaced with pn 602-03-007, 7mm e+ sliding core.The original surgery date was (b)(6) 2015.Similar complaint and dhr review did not add any additional information to the investigation.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.There are multiple reasons ankle pain can occur, including implant loosening/misalignment/failure, scar tissue formation, soft tissue damage, etc.Because further details regarding this complaint are unknown, the source of the pain in this instance cannot be determined and the root cause shall remain unknown.

• Brand Name: STAR
• Common Device Name: SLIDING CORE, UHMPWE,7MM
• 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: 20317542
• Report Number: 1644408-2024-01524
• Device Sequence Number: 7613332
• Product Code: NTG
• UDI-Device Identifier: 00886385026930
• UDI-Public: 00886385026930
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 400-141F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• 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: 71 YR
• Patient Sex: Male