EMPHASYS 4812-01-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 10603295504078), received between May 8, 2023 and Sep 30, 2026 — classified as 212 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (116 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 212 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device-Device Incompatibility

  It was reported that the emphasys impactor threaded part no longer threads.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946332 ↗
• MalfunctionSep 30, 2026Material Deformation

  It was reported that the emphasys straight manual impactor handle was cross threaded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946177 ↗
• MalfunctionSep 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931163 ↗
• MalfunctionSep 28, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921762 ↗
• MalfunctionSep 23, 2026Device-Device Incompatibility

  It was reported that implant gets stuck on threads.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870660 ↗
• MalfunctionAug 5, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141266 ↗
• MalfunctionAug 3, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117272 ↗
• MalfunctionJul 7, 2026Material Deformation

  IT WAS REPORTED THE INSTRUMENT WAS STRIPPED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25731979 ↗
• MalfunctionJul 1, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHEN TRYING TO REPOSITION THE FINAL COMPONENT THE THREADS WERE NOT ENGAGING PROPERLY. THE INSTRUMENT APPEARS TO BE CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677597 ↗
• MalfunctionJun 25, 2026Material Deformation

  IT WAS REPORTED THAT EMPHASYS CUP IMPACTOR CROSS THREADED ONTO THE IMPLANT TWICE. COULD NOT USE THE IMPACTOR AND HAD TO USE A PINNACLE CUP IMPACTOR WITH A 40MM HEAD IMPACTOR ATTACHMENT TO SEAT THE CUP "FREEHAND". IT WAS NOTED THAT THE CUP WAS IN GOOD POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619363 ↗
• MalfunctionJun 22, 2026Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THE EMPHASYS LINER TIP ADAPTOR WAS ATTACHED TO THE IMPACTOR HANDLE. THE SCRUB NURSE SCREWED IT ONTO THE IMPACTOR. THE CASE WAS COMPLETED SUCCESSFULLY. THE STERILE SERVICES TEAM SAID THEY WERE UNABLE TO REMOVED THE ADAPTOR TIP FROM THE HANDLE AFTER A PREVIOUS CASE, SO THEY PROCESSED THE ADAPTOR AND HANDLE AS ONE PIECE. THIS WOULD HAVE PUT THE PATIENT AT AN INFECTION RISK WHEN THE ADAPTOR WAS REMOVED IN ORDER TO ATTACH THE CUP. WE WILL DO EDUCATION WITH THE HOSPITAL STAFF TO ENSURE THE PARTS ARE DISASSEMBLED AFTER THE CASE AND PRIOR TO STERILIZATION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576620 ↗
• MalfunctionJun 17, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE INSTRUMENT THREADS WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536624 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMPHASYS STRAIGHT CUP IMPACTOR WOULD NOT DISENGAGE FROM THE CUP'S THREAD, CAUSING MOVEMENT OF THE CUP DURING IMPLANTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532943 ↗
• MalfunctionJun 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ACETABULAR CUP WAS BONDED/THREADED TO THE HANDLE AND WOULD NOT SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414283 ↗
• MalfunctionJun 3, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE THREADS ON THE EMPHASYS IMPACTOR HANDLE WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375198 ↗
• MalfunctionJun 1, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE EMPHASYS CUP HAD GOT STUCK ON EMPHASYS STRAIGHT CUP IMPACTOR. THE THREADS WERE DETERMINED TO BE DEFECTIVE/DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347922 ↗
• MalfunctionMay 27, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EMPHASYS CUP HANDLE BECAME CROSS THREADED WITH AN EMPHASYS ACETABULAR CUP. IT WAS REPORTED THAT SURGEON WAS ABLE TO REMOVE THE CUP FROM THE HANDLE. IT WAS REPORTED THAT THERE WAS A 2-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300831 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMPHASYS STRAIGHT HANDLE THREADS ARE NOT SCREWING INTO CUP. NO ALLEGATION AGAINST CUP. WE TRIED TO PUT IMPLANT ON REPORTED HANDLE; IT DID NOT GO; OPENED A SECOND HANDLE AND WAS ABLE TO IMPLANT CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161466 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THE HANDLE KEEPS GETTING STUCK IN CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160315 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT EMPHASYS STRAIGHT CUP IMPACTOR BECAME CROSS THREADED ONTO THE EMPHASYS CUP WHILE EXPLANTING AND COULD NOT BE TAKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159199 ↗
• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DAMAGED EMPHASYS CUP HANDLE THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082879 ↗
• MalfunctionMay 4, 2026Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE PROVIDE THE LOT NUMBER AND PRODUCT CODE OF UNK ACETABULAR TRIAL? - THERE WAS NO VISIBLE LOT CODE ON THE CUP TRIAL. PLEASE CLARIFY THE EXACT ALLEGATION OF THE REPORTED PRODUCTS. - WE COULD NOT SEPARATE THE CUP TRIAL FROM THE CUP IMPACTOR AT THE OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072164 ↗
• MalfunctionApr 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT IMPLANT BINDING TO HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046634 ↗
• MalfunctionApr 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT IMPLANT BINDING TO HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046633 ↗
• MalfunctionApr 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT IMPLANT BINDING TO HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046631 ↗