NA 2178-63-176Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295096337), received between Jul 27, 2017 and May 12, 2023 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING THE SURGERY THE BIGGER DIAMETER REAMERS DIDN¿T REAM THE CORTICAL BONE WHEN THE SURGEON HAD TO APPLY GREATER FORCE BECAUSE THE REAMER CONTACTED THE CORTICAL BONE. THE T HANDLE MOVED AROUND ON THE REAMER SHAFT, BUT THE REAMER ITSELF STAYED IN THE MEDULLARY CANAL WITHOUT ANY MOVE (WHEN IT SHOULD MOVE WITH THE T HANDLE). IT IS NOT THE FAULT OF THE REAMER OR THE HANDLE, JUST OVERUSED AND WORN. THERE WAS A SURGICAL DELAY OF FOUR MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918675 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS NO LONGER ATTACH TO ADAPTOR AND T HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590868 ↗
• MalfunctionDec 28, 2021Naturally Worn; Naturally Worn

  THE BUSHING ON THE TIBIAL BROACH IS DAMAGED, WILL NOT ACCEPT A STEM TRIAL. BOTH MODIFIED ADAPTERS ARE STRIPED. 16MM HUDSON IS STRIPED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13092632 ↗
• MalfunctionNov 17, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CONNECTION END OF THESE PARTS IS WORN AND NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829237 ↗
• MalfunctionOct 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REVISION REAMER AND T-HANDLE DIFFICULT TO SEPARATE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724401 ↗
• MalfunctionSep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BOTH HUDSON ADAPTORS WOULD NOT HOLD THE 16 MM REAMER. BOTH THE HUDSONS AND THE REAMER NEEDS TO BE REPLACED. BOTH OF THE TIBIAL BROACHES WOULD NOT HOLD A STEM TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432133 ↗
• MalfunctionAug 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO PIECES WERE BROKEN OFF THE INSTRUMENTS AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12273607 ↗
• MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825402 ↗
• MalfunctionFeb 4, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT MBT REVISION REAMERS ARE WORN DOWN AT THEIR ATTACHMENT POINT AND WILL NOT PROPERLY ATTACH TO THE MODIFIED HUDSON ADAPTER AND NEED TO BE REPLACED. PLEASE SEND REPLACEMENTS TO NORTH CAROLINA SPECIALTY HOSPITAL IN DURHAM, NC. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282615 ↗
• MalfunctionDec 29, 2020Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT T HANDLE, CHUCKS, AND REAMERS ARE ALL DULL AND DO NOT STAY LOCKED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11090063 ↗
• MalfunctionDec 21, 2020Failure to Cut; Material Twisted/Bent; Naturally Worn; Failure to Cut; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT ALL REAMERS ARE STRIPPED AND DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046287 ↗
• MalfunctionDec 17, 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 11027869 ↗
• MalfunctionOct 28, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ITEMS IN THE TC3 REAMER TRAY ARE STRIPPED OUT. PLEASE SHIP TO (B)(6) NEED FOR NEXT WEEK. A SURGICAL DELAY OF 20 MINUTES WAS NOTED.

  Patient problems: No Code Available

  MAUDE report 10750712 ↗
• MalfunctionJul 1, 2020Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE END OF SIZE 16 REAMER IS ROUNDED OFF, DUE TO WEAR WOULD NOT STAY CONNECTED TO THE ADAPTER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10217693 ↗
• MalfunctionApr 3, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TOP OF THE REAMER WHERE IT ATTACHES TO THE HANDLE WAS STRIPPED. TOOK ABOUT 5 MINUTES TO GET IT OUT.

  Patient problems: Not Applicable

  MAUDE report 9922381 ↗
• MalfunctionJan 29, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE 16MM MBT REVISION REAMER WILL NOT ATTACH SECURELY TO THE MODIFIED HUDSON ADAPTER AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644230 ↗
• 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 9496234 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS HAD COMPLAINTS THEY ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240998 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS HAD COMPLAINTS THEY ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240996 ↗
• MalfunctionOct 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT UPON CHECKING THE QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, THEY WERE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240360 ↗
• MalfunctionOct 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT UPON CHECKING THE QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, THEY WERE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240315 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CHECK TOLERANCE ON HUB END COMPLAINTS NOT FITTING PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238512 ↗
• MalfunctionOct 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9151661 ↗
• MalfunctionOct 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9151655 ↗
• MalfunctionSep 27, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ALL REAMERS ARE STRIPPED AND DO NOT STAY ATTACHED TO THE HUDSON. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129108 ↗