EMPHASYS 2999-66-724Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295526353), received between Mar 17, 2023 and Dec 2, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Break; Break

  DURING CASE WITH [SURGEON] DURING A VELYS TKR, AFTER IMPACTING THE CEMENTLESS FEMORAL COMPONENT INTO PATIENT, WHEN REMOVING THE FEMORAL INTRODUCER, THE TOGGLE ON THE SIDE SNAPPED OFF. THE SURGEON WAS ABLE USE THE DIAL WHEEL TO REMOVE THE INTRODUCER SO THERE WAS NO DELAY IN THE OPERATION. THE INSTRUMENT WAS FROM A LOAN SET SENT TO THE HOSPITAL. IT WILL BE DECONTAMINATED, TAGGED AND SENT BACK TO THE WAREHOUSE. IT WILL NEED TO BE FIXED OR REPLACED BEFORE BEING DISPATCHED AGAIN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY NO, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692168 ↗
• MalfunctionFeb 3, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE EMPHASIS MTO TIP FOR THE MAC CURVED INSERTER WAS DAMAGED AND CROSS THREADED INTO THE SHELL. A NEW SHELL WAS OPENED. A SURGICAL DELAY OF 5 MINUTES WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 21291059 ↗
• MalfunctionNov 26, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. DURING THE PROCEDURE, THE ADAPTOR THREADS STRIPPED.

  Patient problems: Insufficient Information

  MAUDE report 20777337 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUP STUCK ON INSERTER. COULD NOT TAKE OFF INSIDE PATIENT. COULD NOT GET OFF AFTER WE TOOK OFF. SURGERY WAS DELAYED 15 MINUTES DUE TO THE REPORTED EVENT. SWITCHED TO PINNACLE CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300441 ↗
• MalfunctionJul 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS BENT WHILE TRYING TO ENGAGE WITH THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 19808035 ↗
• MalfunctionJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON EMSYS CUP ADAPTOR WERE DAMAGED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19466221 ↗
• MalfunctionMay 15, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT EMPHASYS CUP THE KINCISE CUP IMPACTOR WOULD NOT THREAD IN OR STAY THREADED INTO CUP. WE OBSERVED THAT THE THREADS WERE SMASHED AND UNABLE TO WORK. SAME RESULT WHEN UTILIZING THE CURVED MANUAL CUP IMPACTOR. IT IS BELIEVED THE THREADS OF CUP HAD BEEN DAMAGED AND THEN DAMAGED THE SECOND TIP AS WELL. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19320258 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN OFFSET EMPHASYS IMPACTOR. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18962113 ↗
• MalfunctionFeb 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE EMPHASYS CURVED IMPACTOR, THE OFFSET IMPACTOR TIP WAS CONTAMINATED VIA THE C-ARM. THERE WAS A 20 MINUTES OF SURGICAL DELAY .

  Patient problems: Insufficient Information

  MAUDE report 18719796 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON INSERTER ADAPTOR ARE STRIPPED AND WILL NOT ALLOW CUP TO EASILY SCREW ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426106 ↗
• MalfunctionNov 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMPHASYS INSERTER TIP WOULD NOT THREAD ONTO THE CUP SO THE INSERTER TIP ON THE OFFSET INSERTER WAS EXCHANGED AND IT GOT STUCK, RENDERING IT UNUSABLE. THE INSTRUMENTS WERE REMOVED FROM THE FIELD AND ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18218740 ↗
• MalfunctionOct 17, 2023Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE EMPHASYS OFFSET CUP ADAPTER THREADS WERE STRIPPED. IT COULD NOT ATTACH IMPLANT. DID NOT DELAY THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950854 ↗
• MalfunctionAug 10, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499482 ↗
• MalfunctionAug 10, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE TOP THREADS WERE STRIPPED AND COULD NOT THREAD INTO THE CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498776 ↗
• MalfunctionMar 17, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THREADS ON THE EMPHASYS CURVED MI TIP ADAPTOR BENT AND IS NO LONGER THREADING ONTO CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563494 ↗