NA 9632-06-000Recalls & reported problems
Depuy International Ltd · HARDINGE CEMENT RESTRICTOR INTRODUCER - LONG · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Hardinge cement restrictor introducer has 81 adverse event reports mentioning it. The reports mostly describe bent tips, broken parts, worn instruments and material deformation, sometimes during total hip replacement. They mention no deaths and 1 injury. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10603295246015), received between Nov 17, 2017 and Jan 29, 2026 — classified as 1 injury, 80 malfunctions.
The most frequently reported specific device problem is “Break” (65 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.
Reports received per month
Most reported problems
Device problems
- Break65
- Naturally Worn15
- Device-Device Incompatibility8
- Material Deformation7
- Entrapment of Device4
- Crack3
- Material Integrity Problem3
- Scratched Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient24
- Not Applicable4
- Insufficient Information2
- Foreign Body In Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Material Deformation
IT WAS REPORTED THAT POST PROCEDURE, DURING TRAY PROCESSING, IT WAS OBSERVED THAT THE SCREW TIP WAS BENT. IT WAS REPORTED THAT THERE WERE NO ADVERSE PATIENT OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208187 ↗MalfunctionNov 19, 2025Break; Break
IT WAS REPORTED THAT THE HARDINGE INTRODUCER DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597443 ↗MalfunctionOct 27, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE END OF THE HARDING RESTRICTOR INTRODUCER WAS BENT/BLUNT AND IT WAS VERY DIFFICULT TO ATTACH THE RESTRICTOR TO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390846 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE WINGS ON THE TOP OF THE HANDLE WERE BROKEN DURING A TOTAL HIP REPLACEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872139 ↗MalfunctionMar 28, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE HOSPITAL HAS A DAMAGED HARDINGE INTRODUCER. THE THREADED END HAS BEEN BENT OVER. IT'S NOT KNOWN WHEN AND HOW THIS OCCURRED. ADDITIONALLY, TWO PINNACLE DOME DRILLS HAVE ALSO BEEN DAMAGED. IT IS NOT KNOWN WHEN AND HOW THIS OCCURRED. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21717830 ↗MalfunctionFeb 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT´S THREAD DOES NO LONGER HOLD THE CEMENT STOPPER. THERE WAS NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21437508 ↗MalfunctionOct 9, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS FOUND THAT THE TIP OF THE INSTRUMENT CONTAINING THE THREAD IS BENT. THIS INSTRUMENT IS COMPOSED OF ONE PART. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412022 ↗MalfunctionJun 24, 2024Break; Break
IT WAS REPORTED THAT THE ITEM BROKEN INTO 3 SEPARATE PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19594539 ↗MalfunctionMay 7, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT ALL PIECES OF THE BROKEN INSTRUMENT WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260388 ↗MalfunctionApr 29, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE HANDLE OF THE CEMENT RESTRICTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19201408 ↗MalfunctionApr 2, 2024Break; Break
THE HARDINGE INTRODUCER HAS BROKEN THE HANDLERS WHILE THE SURGEON WAS INSERTING THE HARDINGE RESTRICTOR CEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19027987 ↗MalfunctionMar 25, 2024Break; Break
IT WAS REPORTED THAT THE T HANDLE ASPECT OF THE HARDINGE CEMENT RESTRICTOR INTRODUCER SNAPPED OFF. WAS ABLE TO COMPLETE CASE AND USE THE INSTRUMENT BUT ITS NOT FAULTY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18967544 ↗MalfunctionFeb 28, 2024Break; Entrapment of Device; Fracture; Break; Entrapment of Device; Fracture
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE OPERATION WAS DELAYED BY HALF AN HOUR. THEY COULD NOT REMOVE THE BROKEN PART AND PUSHED IT INTO THE MEDULLARY SPACE DISTAL. THE PATIENT NOW HAS AN ADDITIONAL FOREIGN BODY AND THE OPERATION AND ANESTHESIA TOOK LONGER. IT WAS ALSO REPORTED THAT THE INSTRUMENT BROKE INTO 2 PARTS.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 18799910 ↗MalfunctionFeb 7, 2024Break; Naturally Worn; Break; Naturally Worn
THE BELOW INSTRUMENT WAS REPORTED AS BROKEN. THIS IS DUE TO FAIR WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18661500 ↗MalfunctionOct 16, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE THREADS ARE GONE ON THE TIP OF THE INTRODUCER AND NOT SCREWING ON SECURELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940596 ↗MalfunctionSep 6, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE HANDLE BROKE DUE TO WEAR AND TEAR. SURGERY WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17692495 ↗MalfunctionJul 31, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: DURING A LOAN KIT INSPECTION, IT WAS NOTICED THAT HALF OF THE HANDLE SNAPPED OFF. THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17423436 ↗MalfunctionJul 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENTS WAS BROKEN INTO 3 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415259 ↗MalfunctionJul 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENTS WAS BROKEN INTO 3 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415011 ↗MalfunctionJul 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENTS WAS BROKEN INTO 3 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17414884 ↗MalfunctionJul 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENTS WAS BROKEN INTO 3 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17414726 ↗MalfunctionJul 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENTS WAS BROKEN INTO 3 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17414710 ↗MalfunctionMay 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIP OF THESE INSTRUMENTS RE TOO BIG TO FIT THE HARDINGE RESTRICTOR IMPLANTS, SO THEY ARE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894368 ↗MalfunctionMay 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIP OF THESE INSTRUMENTS RE TOO BIG TO FIT THE HARDINGE RESTRICTOR IMPLANTS, SO THEY ARE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894367 ↗MalfunctionFeb 8, 2023Material Deformation; Material Deformation
IT WAS REPORTED ONE OF THE INSTRUMENTS IS SLIGHTLY BENT AT THE TIP AND THE THREADS ARE GONE ON ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16322685 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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