KINCISE 2000-15-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10603295527848), received between Nov 28, 2023 and Sep 16, 2026 — classified as 130 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (63 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 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  It was reported the device threads were broken. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792824 ↗
• MalfunctionSep 10, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721152 ↗
• MalfunctionAug 28, 2026Device-Device Incompatibility

  It was reported that the Adaptor does not lock into Kincise impactor. The issue was observed during surgery with delayThere 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 50500057 ↗
• MalfunctionAug 27, 2026Device-Device Incompatibility

  It was reported that the item was not attaching to Kincise impactor. The issue was observed during surgery with delay 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 50482582 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT THE THREADS OF THE DEVICE WERE CHIPPED DURING SURGERY, RESULTING IN A DELAY. 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 25033123 ↗
• MalfunctionApr 29, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT CONNECT TO THE HANDPIECE. THE ISSUE WAS OBSERVED DURING TESTING. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027969 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT KINCISE 1 EMPHSYS STRGHT IMPCT HAD DAMAGE ON THE THREADS (CHIPPED), WHICH CAUSED A TWO-MINUTE DELAY DURING PRE-SURGERY. THE EVENT OCCURRED WITHOUT ANY PATIENT INVOLVEMENT, AND THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322072 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING SURGERY THE THREAD ON THE KINCISE 1 EMPHSYS STRGHT IMPCT WAS FOUND TO BE CHIPPED. THERE WAS A DELAY IN SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134431 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE METAL EDGE OF THE END THAT GOES INTO THE KINCISE WAS CHIPPED OFF, CAUSING SHARP PIECES TO COME OFF. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841849 ↗
• MalfunctionSep 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ITEM HAD A SHARP METAL SHARD. THE ISSUE WAS OBSERVED DURING TESTING 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 23097359 ↗
• MalfunctionAug 26, 2025Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE THREADS ON THE INSERTER GOT MARRED AS THE INSERTER WAS BEING REMOVED AFTER THE IMPLANTATION OF THE IMPLANT. NO HARM TO THE PATIENT, NO DELAY IN THE CASE. THE ISSUE WAS OBSERVED DURING SURGERY THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893611 ↗
• MalfunctionAug 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE KINCISE ADAPTOR GETS STUCK ON IMPACTOR WHEN REMOVING. THE ISSUE WAS OBSERVED DURING SURGERY . THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893144 ↗
• MalfunctionAug 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EMPHASYS CUP AND KINCISE HANDLE WERE STUCK TOGETHER. THE SURGEON COULD NOT SEPARATE THEM. THEY HAD TO OPEN A NEW CUP AND HANDLE. THE SALES CONSULTANT SUBMITTED A DER FOR THE HANDLE BUT FORGOT THE CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817940 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT EMPHASYS CUP KINCISE ADAPTOR HAS BECOME MISSHAPED AND WILL NO LONGER INSERT INTO KINCISE GUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782970 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT EMPHASYS CUP KINCISE ADAPTOR HAS BECOME MISSHAPED AND WILL NO LONGER INSERT INTO KINCISE GUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782898 ↗
• MalfunctionAug 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ADAPTOR CROSS THREADED. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. THERE WAS NO DELAY AND NO INJURIES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755201 ↗
• MalfunctionAug 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PREOPERATIVELY, THE ADAPTOR CUP WOULDN'T THREAD ONTO THE INSERTER. THERE WAS NO PATIENT INVOLVEMENT. NO DELAYS. 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 22751177 ↗
• MalfunctionAug 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE IMPACTOR WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688288 ↗
• MalfunctionJul 16, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE EMPHASYS ADAPTER IS CROSS THREADED AND CANNOT SECURE A CUP FOR IMPACTION. THE ISSUE WAS OBSERVED POST SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522539 ↗
• MalfunctionJul 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ITEM WAS TESTED PRE SURGERY. THE HANDLE DID NOT ENGAGED TO THE KINCISE. THEY GRABBED A NEW HANDLE SINCE THIS OCCURRED BEFORE THE PATIENT WAS IN THE ROOM. AFTER THE CASE THEY TESTED A SECOND KINCSE TO CONFIRM IT WAS THE ATTACHMENT AND IT WAS THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469672 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE KINCISE EMPHASYS STRAIGHT SHELL IMPACTOR WAS USED IN OVER FIFTY HIP ARTHPLASTIES SURGERIES. DUE TO NORMAL WEAR AND TEAR, THE SCREW TIP THAT FASTENS THE CUP BECAME CROSS THREADED. THE IMPACTOR CANNOT SECURE A CUP WITHOUT GETTING STUCK. THE ISSUE WAS OBSERVED POST SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461441 ↗
• MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE KINCISE EMPHASYS ADAPTER WOULD NOT SCREW INTO THE CUP. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373892 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE INSERTER WOULD NOT COME LOOSE FROM THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344421 ↗
• MalfunctionJun 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUP INSERTER BECAME STUCK ON THE CUP AND WOULD NOT COME LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342013 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE EMPHASYS STRAIGHT KINCISE IMPACTOR HANDLE IS CROSS THREADED. THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332084 ↗