MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; REVISION SLIDING CORE STAR ANKLE 14MM

Catalog Number	99-0028-14F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Poly swap with osteotomy to improve ranfge of motion and alignment.Trilliant surgical is the manufacturer of the device, the device did not cause or contribute to a death or an injury that was life threatening.A malfunction of the device resulting in a failure of the device to perform its essential function which comprises the device's therapeutic effectiveness that could cause or contribute to death or serious injury did not occur.Recurrence of the malfunction is not likely to cause or contribute to a death or serious injury.The device is not considered to be life supporting or life sustaining.The devise was not returned for evaluation, and additional information was not received regarding the reason for the revision surgery.A root cause could not be established.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - poly swap with osteotomy to improve ranfge of motion and alignment.

• Brand Name: STAR
• Common Device Name: REVISION SLIDING CORE STAR ANKLE 14MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 24646415
• Report Number: 1644408-2026-00613
• Device Sequence Number: 21384288
• Product Code: NTG
• UDI-Device Identifier: 00886385027005
• UDI-Public: 00886385027005
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 99-0028-14F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2026
• Initial Report FDA Received Date: 03/19/2026
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male