KINCISERecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of KINCISE by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2022 and Sep 9, 2025 — classified as 21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported KINCISE problems
Device problems
- Device-Device Incompatibility9
- Naturally Worn9
- Material Deformation4
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information6
KINCISE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- KINCISE 2999-66-809INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT12 reports
- KINCISE 2999-66-455INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT8 reports
- KINCISE 2999-66-806INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
Recent KINCISE adverse event reports
The 15 most recent reports across all models, 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 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IT WAS NOT FITTING INTO ANY KINCISE. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22818413 ↗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 ↗MalfunctionJan 24, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREADS WERE STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21233116 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER SNAPPED WHILE TRYING TO REMOVE IMPACTOR FROM COMP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21069051 ↗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 ↗MalfunctionNov 4, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? NO CONSEQUENCE. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO DELAY. C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. THREADS WERE STRIPPED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20600144 ↗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 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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