EMPHASYS 4741-09-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295505488), received between Mar 27, 2025 and Mar 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THERE HAD BEEN A SCENARIO OF AN EMPHASYS STEM NOT SEATING IN THE RIGHT PLACE WHEN USING THE BROACHES ONLY. THE SURGEON USED THE ALTERNATIVE TECHNIQUE OF DISTAL REAMING TO GET THE STEM TO SEAT AS DESIRED. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719570 ↗
• MalfunctionMar 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2025. BROACHING OF THE FEMUR WAS COMPLETED SEQUENTIALLY FROM THE STARTER BROACH THROUGH TO THE SIZE 9 BROACH; CALCAR REAMING WAS PERFORMED ON THE FINAL BROACH. EACH BROACH WAS FULLY SEATED WITHIN THE FEMUR. AFTER TRAILING WAS PERFORMED, THE SURGEON WAS HAPPY WITH STABILITY AND IMPLANT POSITIONING. FINAL STEM WAS CHOSEN, CONFIRMED BY SURGEON, AND OPENED. DURING FINAL STEM INSERTION OF THE SIZE 9 STANDARD EMPHASYS STEM, THE SURGEON STATED THAT THE STEM WOULD NOT SEAT FULLY; IT WAS SITTING APPROXIMATELY 3CM PROUD. THE SURGEON CHOSE TO USE NON-DPS FLEXIBLE REAMERS. REAMERS WERE USED IN SEQUENTIAL ORDER UNTIL 14, 15, AND 16MM. AN ATTEMPT WAS MADE TO INSERT THE STEM FOLLOWING EACH OF THESE REAMINGS. AFTER THE 16MM REAMER WAS USED, THE STEM WAS FINALLY ABLE TO BE FULLY SEATED WITH THE COLLAR CONTACTING THE CALCAR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710530 ↗