MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; EMPOWR POROUS FEMUR WITH HA NANO, 7L

Model Number	244-01-107
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The pressfit femur did not full grow in.This caused it to become lose.It had to be taken out and a cemented femur was used.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number cc-00393678_1644408-2022-01693; 244-02-105, s810 - device loosening, revision surgery.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: EMPOWR POROUS FEMUR WITH HA NANO, 7L
• 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: 24609456
• Report Number: 1644408-2026-00444
• Device Sequence Number: 13158246
• Product Code: MBH
• UDI-Device Identifier: 00190446364481
• UDI-Public: 00190446364481
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/16/2026

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: 244-01-107
• Device Lot Number: 3248A1037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• 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: 341-11-707 4011A1029
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male