MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; EMPOWR BLADE STEM, STEM, COXA VARA, SIZE 7

Model Number	425-93-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Did a primary total hip on date the patient presented on date with a periprosthetic femur fracture.Dr.Did a revision by removing the empower blade stem, 28mm ceramic head, and dm poly bearing and implanted an exprt revision stem and a new 28 ceramic head and dm poly bearing.He also fixed the proximal femur fracture with cables.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number (b)(4); 425-98-011, s809 - trauma, 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 BLADE STEM, STEM, COXA VARA, SIZE 7
• 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: 24760285
• Report Number: 1644408-2026-00574
• Device Sequence Number: 10305589
• Product Code: KWY
• UDI-Device Identifier: 00190446759126
• UDI-Public: 00190446759126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223779
• 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): 04/01/2026

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: 425-93-007
• Device Lot Number: 4403A1002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-281, 857B1402.; 952-28-38D, 2223A1149.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female