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

Catalog Number	UNK-STAR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
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 - poly swap, due to cysts.
Additional Manufacturer Narrative
See d4, h6, h10 and h11 complaint has been evaluated and is similar to report number 1644408-2025-00207; unk-star; s901 - other if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• 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: 23640726
• Report Number: 1644408-2025-01750
• Device Sequence Number: 9978585
• Product Code: NTG
• UDI-Device Identifier: 00810028393509
• UDI-Public: 00810028393509
• 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 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): 04/27/2026

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: UNK-STAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/27/2026
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male