NA 2178-63-106Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TAPERED CEMENT REAMER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy MBT revision tapered cement reamer, a surgical instrument used to prepare the bone for a hip replacement. The 46 reports mostly describe the reamer not gripping properly, coming loose or spinning on its handle, and wearing down or bending during use, sometimes forcing surgeons to extend the operation. One report mentions pain in a patient's hand; no deaths were reported. 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
- 46
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295096054), received between Sep 14, 2017 and May 19, 2025 — classified as 1 injury, 45 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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
- Device-Device Incompatibility15
- Material Deformation10
- Naturally Worn9
- Material Twisted/Bent8
- Appropriate Device Problem Term/Code Not Available5
- Loose or Intermittent Connection5
- Break3
- Component Missing3
Patient problems
- No Consequences Or Impact To Patient28
- No Clinical Signs, Symptoms or Conditions7
- No Information5
- Not Applicable3
- Bone Fracture(s)1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2025Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility
IT WAS REPORTED THAT INTRAOPERATIVELY DURING A SURGERY WITH A SHORT-TERM-LOANER KIT, THE SURGEON FOUND THE REAMER TO BE BLUNT AND THE CLAMP JAMMED. THIS CAUSED A SURGERY PROLONGATION OF ABOUT 15 MINUTES. IN ADDITION, WHILE TRYING TO REMOVE THE BLUNT REAMER FROM THE MACHINE, THE SURGEON'S HAND WAS HIT BY THE MACHINE (NON-DEPUY PRODUCT), AND HE SUBSEQUENTLY COMPLAINED OF PAIN.
Patient problems: Pain
MAUDE report 22043570 ↗MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE WOULD NOT SECURELY HOLD WHILE REAMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777708 ↗MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE WOULD NOT SECURELY HOLD WHILE REAMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777692 ↗MalfunctionApr 30, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE MBT REAMERS WERE SLIPPING IN THE HUDSON ADAPTER AND T-HANDLE DURING THE CASE. AFTER THE CASE, THE INSTRUMENTS SHOWED WEAR DUE TO USAGE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11758421 ↗MalfunctionApr 12, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT NEITHER MBT CONCICAL REAMER WILL MATE WITH STEM TRIALS. STEM TRIALS WOULD DISENGAGE FROM REAMERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11653153 ↗MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE MBT MODIFIED HUDSON ADAPTORS STRIPPED WHILE REAMING. MBT CONICAL REAMER AND CEMENTED REAMER ALSO TRIPPED IN CHUCK DURING REAMING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11172839 ↗MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ALL REAMERS WERE LOOSE ON THE ADAPTERS AND SPUN FREELY. ADAPTER WOULD SPIN FREELY WHEN ATTACHED TO REAMERS OR ANY OTHER ATTACHMENT. T-HANDLE WAS ALSO LOOSE. ATTACHMENT POINT SEEMS TO BE WEAK AND CAME FREE AT FIRST SIGN OF RESISTANCE. NO PIECES BROKE OFF IN PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 30 AS A RESULT OF DEPUY INSTRUMENTS NOT FUNCTIONING PROPERLY.
Patient problems: Insufficient Information
MAUDE report 11057357 ↗MalfunctionDec 4, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT MODIFIED HUDSON ADAPTER ROUNDED OFF THE STEM OF THE REAMER. THERE WERE NO PIECES BROKEN OFF. THIS IS ALL THE INFORMATION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10944678 ↗MalfunctionDec 1, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS THAT THE THREE INSTRUMENTS WERE BROKEN DURING THE SURGERY. THE MODIFIED HUDSON ADAPTOR WOULD NOT LOCK THE REAMER IN PLACE. THE REAMER STEM WAS ROUNDED OFF, AND THE TIBIAL VIEW PLATE WAS BROKEN IN 2 PIECES. ALL PIECES WERE RECOVERED. IT DID NOT EXTEND THE TIME OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10931090 ↗MalfunctionSep 15, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AN MBT REV PRIMARY CONICAL REAMER AND AN MBT REV TAPERED CEMENT REAMER BEGAN TO SPIN IN BOTH MODIFIED HUDSON ADAPTERS. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10535490 ↗MalfunctionMar 27, 2020Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION THEY NOTICED THAT THE ORANGE RING INSIDE THE CANAL OF THE REAMER WAS MISSING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889102 ↗MalfunctionMar 12, 2020Component Missing; Device-Device Incompatibility; Material Deformation; Component Missing; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT WHEN THE TRIAL STEM WAS ATTACHED TO THE CONICAL REAMER. THE STEM WOULDN'T STAY ENGAGED TO THE REAMER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9824083 ↗MalfunctionFeb 27, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE HUDSON ADAPTER WAS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9764657 ↗MalfunctionJan 28, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE MBT CONICAL REAMER SLIPPING IN ADAPTER, EDGES WAS ROUNDED OFF. NEEDS REPLACEMENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9637628 ↗MalfunctionDec 26, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMER WILL NO LONGER HOLD A STEM TRIAL. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9520004 ↗MalfunctionDec 19, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
THE SURGEON EXPERIENCED PROBLEMS WITH THE MODIFIED HUDSON ADAPTERS (217863136)SPINNING ON THE END OF SEVERAL REAMERS,SPECIFICALLY DUE TO WEAR.
Patient problems: Not Applicable
MAUDE report 9496217 ↗MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE RED RUBBER TIP RIPPED NOT ALIGNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9239496 ↗MalfunctionJul 26, 2019Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking
IT WAS REPORTED THAT THE STEM WOULD NOT SEAT IN EITHER REAMER. STEM ALSO BECAME STUCK IN REAMER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8831113 ↗MalfunctionJul 26, 2019Break; Material Deformation; Break; Material Deformation
BROKEN EQUIPMENT PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.
Patient problems: Not Applicable
MAUDE report 8830994 ↗MalfunctionJul 16, 2019Dull, Blunt; Material Deformation; Naturally Worn; Dull, Blunt; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE T HANDLE AND HUDSON ADAPTER HAVE STRIPPED AT THE ENDS. CONICAL REAMERS ARE DULL AND NEEDS TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8795392 ↗MalfunctionJun 4, 2019Component Missing; Device-Device Incompatibility; Material Deformation; Scratched Material; Component Missing; Device-Device Incompatibility; Material Deformation; Scratched Material
STEM TRIALS ARE NOT ABLE TO BE SECURELY FIXATED ON END OF REAMER. REALIZED DURING SURGERY, RESULTED IN NO DELAY. ITEM DID NOT BREAK INTO 2 OR MORE PIECES. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? -- NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? -- YES, WERE FRAGMENTS GENERATED? -- NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8666814 ↗MalfunctionMay 14, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMER HEAD WAS NOT LOCKING INTO CHUCK ADAPTER. IT KEEPS SLIPPING OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609616 ↗MalfunctionMay 6, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE MBT REV TAPERED CEMENT REAMER'S CONNECTOR WAS WORN AND WILL NO LONGER ENGAGE WITH HUDSON ADAPTOR. NEEDS REPLACING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583181 ↗MalfunctionFeb 28, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
THE HUDSON ATTACHMENT OF THIS REAMER WAS WORN DOWN. WHEN USED ON POWERED HUDSON REAMER AND T-HANDLE REAMER, (TRIED TO USE WITH AND WITHOUT ADAPTOR IN INSTRUMENT SET) IT WOULD SPIN OUT WHEN THE REAMER MET RESISTANCE FROM THE BONE IT WAS SUPPOSED TO REAM. THEREFORE NOT ABLE TO REAM THE BONE. THIS REAMER NEEDS TO BE USED TO CLEAR BONE BEFORE BROACHING. NO AE TO THE PATIENT, 10 MINUTES DELAY IN THE SURGERY.
Patient problems: Not Applicable
MAUDE report 8379365 ↗MalfunctionFeb 12, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE MBT REV PRIMARY REAMER WAS ROUNDED OFF WHERE IT ATTACHES TO THE HUDSON. MBT REV CAM STEM REAMER WAS ROUNDED OFF WHERE IT ATTACHES TO THE HUDSON. BROACH REAMER WAS CROSSED THREADED INSIDE. MODIFIED HUDSON ADAPTER WAS ROUNDED OFF AT THE CONTENTION. REV REAMER T HANDLE WAS ROUNDED OFF AT THE CONTENTION. REVISION FEMORAL BROACH HANDLE WAS WORN WHERE IT ATTACHES TO THE BROACHES AND WILL NO LONGER GRAB PROBABLY. THE TIP OF FEMORAL AUG PLUG PULLER WAS WORN DOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8330848 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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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