MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; EMPOWR 3D KNEETM INS, 5R 10MM, VE

Model Number	342-10-705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: the agent reported, "the poly had not locked into the tibial baseplate so we had to remove and reinsert a new poly." item number: 342-10-705, "item description: empowr 3d kneetm ins, 5r 10mm, ve," lot#: 075t1236, part revision: d, product type: knee, manufacture date: 20-mar-2025, expiration date: 17-mar-2030.This event occurred during surgery, near the patient.The surgeon reported no risk or adverse event, and the surgery was completed as intended with no delay.The implant was inspected prior to use and deemed acceptable based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the reported device was not returned to enovis surgical for evaluation.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Root cause: the root cause of this complaint was a revision surgery due to improper seating of the polyethylene insert, likely due to inadequate alignment and/or impaction technique preventing full engagement into the tibial baseplate locking mechanism.This is an event associated with surgical error, not an event associated with product failure, malfunction, or issue.Containment: there are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Device history records review: a review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.Complaint history: the customer complaint history for the reported device(s) showed no current trends or ongoing issues that require review.
Event or Problem Description
The poly had not locked into the tibial baseplate so we had to remove and reinsert a new poly.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR 3D KNEETM INS, 5R 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: 25129483
• Report Number: 1644408-2026-00864
• Device Sequence Number: 21136961
• Product Code: JWH
• UDI-Device Identifier: 00888912167321
• UDI-Public: 00888912167321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/08/2026

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: 342-10-705
• Device Lot Number: 075T1236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 100 KG