KINCISE 200003002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07612334268778), received between Sep 18, 2025 and Aug 21, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379541 ↗
• MalfunctionJun 23, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EMPHASYS SHELL/LINER IMP OFFS CONNECTOR PIECE AT THE END THAT CONNECTS TO THE IMPACTOR WAS DAMAGED CAUSING IT TO GET STUCK TO THE IMPACTOR. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600194 ↗
• MalfunctionFeb 4, 2026Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SHELL/LINER IMPACTOR DEVICE'S CUP INSERTER THREADS HAD BEEN STRIPPED AND THE DEVICE HAD BROKEN INTO MULTIPLE PIECES. NO PIECES WERE LEFT IN THE PATIENT. 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 24258612 ↗
• MalfunctionDec 5, 2025Break; Material Fragmentation; Nonstandard Device; Device-Device Incompatibility; Break; Material Fragmentation; Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE SHELL IMPACTOR DEVICE WAS BROKEN WHERE THE ADAPTOR CONNECTS TO THE MANUAL HANDLE OR GUN. IT WAS REPORTED THAT THERE ARE BARBS IN THE METAL THAT MAKES IT SO IT WOULD NOT ATTACH. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727625 ↗
• MalfunctionNov 20, 2025Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BLACK TIP ON THE HEAD OF THE FEMORAL HEAD IMPACTOR - SHAFT DEVICE BROKE. THERE WAS NO REPORTS OF DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604508 ↗
• MalfunctionOct 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EMPHASYS SHELL/LINER IMP OFFS DEVICE COULD NOT RELEASE THE CUP-DAMAGED END. THERE WAS UNSPECIFIED SURGICAL AMOUNT OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368356 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEW OFFSET SHELL/LINER IMPACTOR DEVICE DID NOT SPIN FREELY AT THE END THAT SCREWED INTO THE CUP. AS A RESULT, THE CAP COULD BE PLACED ON THE INSERTER, BUT ONCE IMPLANTED, IT COULD NOT BE REMOVED WITH A SCREWDRIVER. THE DEVICE HAD NEVER BEEN USED. IT WAS REPORTED THAT ANOTHER DEVICE WAS OPENED AND USED WITHOUT ISSUES. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE. 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 23086736 ↗