MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; EMPOWR 3D KNEE INS, 9L 10MM, VE

Model Number	341-10-709
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number (b)(4); 341-12-711 and s800 - revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Patient was scheduled to have hardware removed (cancellous screw and washer) and the doctor decided to exchange the poly insert at the same time.Male 54yrs.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR 3D KNEE INS, 9L 10MM, VE
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 24408307
• Report Number: 1644408-2026-00286
• Device Sequence Number: 10114019
• Product Code: JWH
• UDI-Device Identifier: 00888912166867
• UDI-Public: 00888912166867
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/20/2026

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 Model Number: 341-10-709
• Device Lot Number: 069T1174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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: 54 YR
• Patient Sex: Male