MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; FA - PR-21-003 STAR E+ SLIDE CORE IMPLANT (DWG 302-03-000)

Catalog Number	602-03-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/09/2025
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 poly wear.
Additional Manufacturer Narrative
See h10 and h11.Similar complaint 1644408-2025-00207 was related to cyst formation.In both complaints, limited information is available regarding the original surgical technique and what occurred that could have contributed to the complaint event between the original and revision surgeries.There are many potential causes for cyst formation; because the physiological conditions and details of what occurred in the 10 years following the original surgery are unknown, the root cause will remain unknown at this time.

• Brand Name: STAR
• Common Device Name: FA - PR-21-003 STAR E+ SLIDE CORE IMPLANT (DWG 302-03-000)
• 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: 21973476
• Report Number: 1644408-2025-00635
• Device Sequence Number: 20620812
• Product Code: NTG
• UDI-Device Identifier: 00810028393516
• UDI-Public: 00810028393516
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D449216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 602-03-010
• Device Lot Number: 2315285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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 Sex: Unknown