EMPHASYS 4812-01-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10603295504061), received between Dec 19, 2023 and Sep 21, 2026 — classified as 89 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (56 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848636 ↗
• MalfunctionSep 21, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846485 ↗
• MalfunctionAug 7, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175095 ↗
• MalfunctionAug 5, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143866 ↗
• MalfunctionAug 5, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143794 ↗
• MalfunctionJul 27, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038827 ↗
• MalfunctionJul 8, 2026Material Deformation

  IT WAS REPORTED THAT EMPHASYS OFFSET CUP INSERTER THREADS ARE DAMAGED WHICH CAUSED CROSS THREADING OF THE TRIAL CUP. THE SURGEON DECIDED TO USE THE STRAIGHT IMPACTOR AND THERE WAS NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748584 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMPHASYS CUP DID NOT COME OFF THE HANDLE. THE CUP WAS EITHER LOOSE OR TOO TIGHT AND DID NOT COME OFF THE CUP INSERTER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534366 ↗
• MalfunctionMay 29, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMPHASYS OFFSET HANDLE THREADS DID NOT LOCK ONTO THE CUP AND KEPT SPINNING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334809 ↗
• MalfunctionMay 21, 2026Material Deformation

  IT WAS REPORTED THAT WHEN THE EMPHASYS CUP WAS THREADED ONTO THE INSERTER, THE CUP DID NOT FULLY LOCK AND ROTATED SLIGHTLY UPON INSERTION INTO THE ACETABULUM. THERE WAS NO PROBLEM WITH THE CUP; IT THREADED ONTO ANOTHER IMPACTOR WITHOUT ISSUE AND WAS IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243794 ↗
• MalfunctionMay 13, 2026Material Deformation

  IT WAS REPORTED THAT THREADS BECAME CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159681 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT THE INTERNAL SHAFT OF THE OFFSET REAMER BROKE AND THE OFFSET IMPACTOR THREADING WAS DAMAGED, WHICH PREVENTED IT FROM LOCKING. THE CUP HANDLE WAS ALSO CROSS-THREADED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092691 ↗
• MalfunctionApr 13, 2026Material Deformation

  IT WAS REPORTED THAT THE THREADS WERE STRIPPED ON THE EMPHASYS CURVED INSERTER. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865685 ↗
• MalfunctionApr 2, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE STUCK TO THE CUP WHILE IMPACTING THE CUP. BOTH THE CUP AND HANDLE HAD TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764427 ↗
• MalfunctionMar 25, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE CUP DEVICE WOULD NOT COME OFF THE INSERTION HANDLE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REPOSITION THE CUP A FEW TIMES AND THEY BELIEVE IT TIGHTENED THE MATING MECHANISM SO THAT THE CUP WOULD NOT COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690786 ↗
• MalfunctionMar 20, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING THE REAL CUP IMPLANTATION, THE INCLINATION GUIDE ADAPTOR WAS ATTACHED TO THE IMPACTOR TO CHECK THE ALIGNMENT OF THE IMPACTOR. AFTER CONFIRMING ALIGNMENT, THE INCLINATION GUIDE ADAPTOR COULD NOT BE DETACHED. THE SURGEON USED KOCHER FORCEPS TO REMOVE THE ADAPTOR, BUT IT WAS UNSUCCESSFUL. IMPACTING USING A HAMMER WAS PERFORMED WHILE THE ADAPTOR WAS STILL ATTACHED, AND THE VIBRATION FROM THE IMPACTING CAUSED THE ADAPTER TO FALL OFF, AND THE ADAPTOR BECAME UNCLEAN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647830 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CURVED INSERTION HANDLE WOULD NOT DISLODGE FROM REAL IMPLANT. HAD TO REMOVE IMPLANT THAT WAS STILL CONJOINED WITH INSTRUMENT. HAD TO OPEN NEW CUP AND NEW INSTRUMENT CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574958 ↗
• MalfunctionMar 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON HAD AN ISSUE TIGHTENING ON THE EMPHASYS CUP ON THE CUP INSERTER. THE CUP WAS ROTATING ON THE INSERTER UPON INSERTION AND MADE IT DIFFICULT TO POSITION THE CUP IN THE ACETABULUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519407 ↗
• MalfunctionMar 4, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SOMETHING WAS WRONG WITH THE THREADS, ON THE FIRST USE EVER A CUP TRIAL GOT STUCK AND WILL NOT COME OFF. THEY NEED THE HANDLE, 50 CUP TRIAL, AND SCREWDRIVER. THE THREADS WOULD NOT LET GO OF THE CUP NO MATTER HOW HARD ANYONE TRIED TO UNTHREAD IT. THEY ARE POSSIBLY CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511463 ↗
• MalfunctionFeb 20, 2026Break; Corroded

  IT WAS REPORTED THAT THE METAL FINISH WAS DETERIORATING AND CHIPPED AND COULD NOT ENSURE STERILITY. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402545 ↗
• MalfunctionFeb 12, 2026Material Deformation

  IT WAS REPORTED THAT THE CURVED INSERTER WAS CROSS THREADED, NOT BROKEN DURING SURGERY. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321595 ↗
• MalfunctionFeb 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CUP WOULDN'T THREAD ONTO INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262125 ↗
• MalfunctionFeb 2, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE ASSEMBLING THE CUP ONTO THE HANDLE, THE THREAD WOULD NOT ENGAGE FULLY. IT WAS REMOVED AND ANOTHER HANDLE WAS USED TO IMPLANT. THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237288 ↗
• MalfunctionJan 28, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CUP HANDLE WAS STUCK ON CUP DURING CUP IMPLANTATION. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199167 ↗
• MalfunctionDec 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT EMPHASYS CUP IMPACTOR WAS CROSS THREADED. ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877080 ↗