KINCISE 2999-66-809Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295535522), received between Nov 20, 2023 and Sep 9, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS USING KINCISE OFFSET EMPHASYS CUP INSERTER. WHEN TRYING TO REMOVE THE DEVICE, THE TIP OF THE SCREWDRIVER BROKE. ALL PIECES RETRIEVED. NO DELAYS AS SALES CONSULTANT HAD HANDHELD READY TO GO. NO HARM WAS DONE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011832 ↗
• MalfunctionAug 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ITEM WAS CROSS THREADED WHILE ASSEMBLING DURING TESTING. THE ISSUE WAS OBSERVED IN PRE-SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22876872 ↗
• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREADS OF KINCISE/EMPHASYS CUP IMPACTOR WAS CROSS THREADING. THE EVENT DID NOT HAPPENED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819183 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE CASE, IT WAS A CHALLENGE TO THREAD THE IMPACTOR ONTO THE CUP. SALES REPRESENTATIVE CHECKED DEVICE AFTER PROCEDURE AND WHEN DOING SO, THE IMPACTOR AND A 60MM EMPHASYS TRIAL CUP BECAME STUCK TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700743 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED A BROKEN HANDLE OCCURRED ON AN UNKNOWN DATE. NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21263809 ↗
• MalfunctionNov 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL NARRATIVE: NO THE INSTRUMENTS DID NOT BREAK INTO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800140 ↗
• MalfunctionJun 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THREADS WERE DAMAGED ON THE END OF THE DEVICE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528352 ↗
• MalfunctionMay 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS USING EMPHASYS KINCISE OFFSET INSERTER. AS SURGEON FIXED KINCISE TO IMPLANT EMPHASYS CUP WOULD START SPINNING.. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370159 ↗
• MalfunctionMay 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS USING EMPHASYS KINCISE OFFSET INSERTER. AS SURGEON FIXED KINCISE TO IMPLANT EMPHASYS CUP IT WOULD START SPINNING. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19358104 ↗
• MalfunctionApr 26, 2024Naturally Worn; Naturally Worn

  WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195222 ↗
• MalfunctionMar 7, 2024Naturally Worn; Naturally Worn

  THREADS ON THE EMPHASYS KINCISE OFFSET WERE GETTING CROSS THREADED WHEN TRYING TO THREAD ONTO CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862879 ↗
• MalfunctionNov 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT WHILE LOADING THE EMPHASYS CUP ON THE OFFSET KINCISE EMPHASYS CUP IMPACTOR THE THREADS STRIPPED ON THE IMPACTOR TIP AND WE WERE NOT ABLE USE THE CUP IMPACTOR. WE HAD TO OPEN HAND INSERTER. THE CASE WAS DELAYED 2MINS, THE PATIENT WAS NOT HARMED AND NO PIECES WERE NEEDED TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168823 ↗