MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)

Catalog Number	400-140F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the sales rep, the patient underwent surgery because of suspected infection.The original intent was to explant the star system.Upon examination in the surgical setting, the doctor determined there was no infection.As is typical with articulating orthopedic implants, the polyethylene component was replaced while the ankle was exposed as a process for extending the life of the implant of the total joint as the polyethylene tends to be the time limiting component due to natural and expected wear through normal use.Not defect or failure was identified and/or the cause of the revision.
Event or Problem Description
Revision surgery - due to suspected infection and poly swap.

• Brand Name: STAR
• Common Device Name: SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
• 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: 21931584
• Report Number: 1644408-2025-00541
• Device Sequence Number: 12924440
• Product Code: NTG
• UDI-Device Identifier: 00886385026923
• UDI-Public: 00886385026923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 04/29/2025

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: 400-140F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 04/29/2025
• 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: 72 YR
• Patient Sex: Male