MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; TIBIAL COMP,SINGLECOATED US VERSION, LARGE

Catalog Number	400-263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/15/2024
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
See d6 and h11.The removal surgery occurred because of a confirmed staph infection.The initial surgery occurred approximately 12 years ago, followed by a revision surgery 2 years prior to the removal, so it is unlikely the infection was caused by the 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.Dhr review, surgical technique review, and simulated use testing would not have been useful because the reporter clearly shared the following: that there "were no mechanical issues with the ankle" and that the implants were removed because of the surgeon's "precautionary judgement.".

• Brand Name: STAR
• Common Device Name: TIBIAL COMP,SINGLECOATED US VERSION, LARGE
• 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: 20691763
• Report Number: 1644408-2024-01753
• Device Sequence Number: 7230188
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: 00886385016542
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 02/06/2025

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: 400-263
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 400-255 LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female