MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR 3D KNEETM INS, 10L 11MM, VE

Catalog Number	341-11-710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, "removal of implants for treatment of infection where temporary spacer was placed.Male 66." the previous surgery and the surgery detailed in this event occurred 5 months, 29 days apart.Item number: 243-01-110 "item description: empowr 3d kneetm, press fit femur, 10l", lot#: unknown, part revision: na, product type: knee, manufacture date: unknown, expiration date: unknown.This evaluation is limited in scope as limited information was provided to enovis surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.Root cause: the root cause of this complaint was a revision surgery due to infection requiring removal of the femoral component and polyethylene insert, with subsequent replacement of the femoral component and upsizing of the polyethylene insert while retaining the tibial baseplate.No information was submitted with the complaint regarding the patient's pre-existing conditions or any patient activities that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of the control of enovis surgical.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: given the limited information, an extensive search of djo records for an invoice of the previous surgery produced no results, therefore, without the records this investigation cannot lead to a firm conclusion.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.
Event or Problem Description
Revision surgery due to infection.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR 3D KNEETM INS, 10L 11MM, VE
• 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
• MDR Report Key: 25369525
• Report Number: 1644408-2026-01044
• Device Sequence Number: 10552179
• Product Code: JWH
• UDI-Device Identifier: 00190446736097
• UDI-Public: 00190446736097
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 07/24/2026

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: 341-11-710
• Device Lot Number: 4023A1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 341-11-710 LOT: 4023A1016.; 353-01-110 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male