MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; REVISION SLIDING CORE STAR ANKLE 12MM

Catalog Number	99-0028-12F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2024
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 implant broke.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2024-02047; similar complaint (b)(4) involved a star ankle revision surgery due to polyethylene component breakage.In both complaints, the breakage occurred in the 6-7 year duration between the previous surgery and the current revision.The physiological conditions over time that led to implant breakage are unknown and therefore cannot be replicated.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: STAR
• Common Device Name: REVISION SLIDING CORE STAR ANKLE 12MM
• 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: 21074524
• Report Number: 1644408-2024-02048
• Device Sequence Number: 6832090
• Product Code: NTG
• UDI-Device Identifier: 00886385026985
• UDI-Public: 00886385026985
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 99-0028-12F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Male