NA 5460-02-000Recalls & reported problems
Depuy (Ireland) · CEMENT RESTRICTOR INSERTER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy cement restrictor inserter is a hand tool used in hip surgery to place a cement restrictor. The 32 reports mostly describe worn or bent threads and broken parts, along with faded numbers and lines on the handle that left the instrument unusable or taken out of service. No deaths and no injuries were reported, and in most cases surgery continued without harm to the patient. No recalls name 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295174318), received between Feb 27, 2018 and Sep 15, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (27 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
- Naturally Worn27
- Material Twisted/Bent10
- Break6
- Illegible Information5
- Device-Device Incompatibility4
- Material Deformation2
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777688 ↗MalfunctionJan 6, 2025Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE HOSPITAL HAD FOUR TRAYS THAT WERE OUT OF ACTION WITH BROKEN INSTRUMENTS. THE ATTUNE PATELLA RING WAS TORN IN TWO PIECES. THE CEMENT RESTRICTOR INSERTER HAD FADED NUMBERS ON THE HANDLE. THE PINNACLE CUP IMPACTOR ROD THAT CONNECTS THE HANDLE WITH THE TIGHTENING KNOB WAS SPLIT IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078514 ↗MalfunctionAug 21, 2024Material Discolored; Material Deformation; Naturally Worn; Material Discolored; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE THREADS ON CEMENT RESTRICTOR HANDLE ARE BENT AND STRIPPED. NO HARM TO THE PATIENT AND NO DELAY IN SURGERY. LOT NUMBER NOT AVAILABLE DUE TO FADING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20019291 ↗MalfunctionAug 13, 2024Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE NUMBERS AND LINES HAVE FADED ON THE INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19973565 ↗MalfunctionApr 4, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE THREADED END IS BLUNT AND NO LONGER HOLDS A CEMENT RESTRICTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040821 ↗MalfunctionDec 1, 2023Break; Naturally Worn; Break; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? NO, BOTH ARE CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18252480 ↗MalfunctionDec 1, 2023Break; Naturally Worn; Break; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? -NO, BOTH ARE CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18252477 ↗MalfunctionOct 26, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18013550 ↗MalfunctionSep 5, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SCREW THREADS OF THE CEMENT RESTRICTOR HAS DIMINISHED. TRIAL CANNOT BE DONE APPROPRIATELY AS IT CANNOT BE SCREWED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17684617 ↗MalfunctionAug 7, 2023Material Discolored; Naturally Worn; Material Discolored; Naturally Worn
DEVICE REPORT FROM DEPUY SYNTHES UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: THIS RESTRICTOR WAS REPORTED WORN AS THE MARKINGS ARE FADED. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17469130 ↗MalfunctionMay 16, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT LASER MARKINGS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16938078 ↗MalfunctionApr 4, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
SURGEON COULD NOT READ ETCHED MARKINGS ON INSERTER DUE TO THEM BEING WORN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16677821 ↗MalfunctionMar 6, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE MEASUREMENT WRITING ON THE HANDLE HAS RUBBED OFF WITH WEAR AND TEAR AND THE NUMBERS CAN¿T BE READ ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16485648 ↗MalfunctionMay 12, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THREADS ON INSTRUMENT ARE STRIPPED/WORN RESULTING IN INABILITY TO ATTACH TO TRIAL. NO DELAY ON SURGERY, NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14371637 ↗MalfunctionFeb 7, 2022Break; Break
INSTRUMENTS BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13477099 ↗MalfunctionFeb 2, 2022Naturally Worn; Naturally Worn
CEMENT RESTRICTOR INSERTERS ARE WORN/BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423329 ↗MalfunctionFeb 2, 2022Naturally Worn; Naturally Worn
CEMENT RESTRICTOR INSERTERS ARE WORN/BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423325 ↗MalfunctionFeb 2, 2022Naturally Worn; Naturally Worn
CEMENT RESTRICTOR INSERTERS ARE WORN/BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423323 ↗MalfunctionFeb 2, 2022Naturally Worn; Naturally Worn
CEMENT RESTRICTOR INSERTERS ARE WORN/BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423314 ↗MalfunctionFeb 2, 2022Naturally Worn; Naturally Worn
CEMENT RESTRICTOR INSERTERS ARE WORN/BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423313 ↗MalfunctionFeb 2, 2022Naturally Worn; Naturally Worn
CEMENT RESTRICTOR INSERTERS ARE WORN/BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423306 ↗MalfunctionDec 23, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSERTER IS BROKEN. NO IMPACT ON PATIENT. NO DELAY ON SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13077986 ↗MalfunctionJul 8, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
REPORTING 8 X CEMENT RESTRICTOR INTRODUCERS AS THE DEPTHS MARKERS ARE NOW TOO WORN TO READ. THERE ARE NO ADVERSE EVENTS TO REPORT AND THIS HAS NOT AFFECTED SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12135502 ↗MalfunctionJul 8, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
REPORTING 8 X CEMENT RESTRICTOR INTRODUCERS AS THE DEPTHS MARKERS ARE NOW TOO WORN TO READ. THERE ARE NO ADVERSE EVENTS TO REPORT AND THIS HAS NOT AFFECTED SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12135501 ↗MalfunctionJul 8, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
REPORTING 8 X CEMENT RESTRICTOR INTRODUCERS AS THE DEPTHS MARKERS ARE NOW TOO WORN TO READ. THERE ARE NO ADVERSE EVENTS TO REPORT AND THIS HAS NOT AFFECTED SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12135496 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page