NA 2178-63-178Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295096351), received between Jul 27, 2017 and Nov 29, 2023 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE 18MM MBT REV REAMER AND HUDSON ADAPTER STARTED SPINNING WHILE REAMING. THE PIECES WERE ROUNDED OFF AND WOULD NOT WORK. NO HARM TO THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229864 ↗
• 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 16918673 ↗
• MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ADAPTER WILL NOT HOLD ON TO REAMER UNDER HIGH TORQUE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637492 ↗
• 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 16590866 ↗
• 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 12829265 ↗
• MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825417 ↗
• MalfunctionFeb 9, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CONNECTING PART OF THE REAMER WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301114 ↗
• 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 11282578 ↗
• MalfunctionJan 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO REAMERS FROM THE MBT REAMER SET ARE STARTING TO SHOW WEAR ON THE CONNECTION END. THE T-HANDLE AND MODIFIED HUDSON ADAPTER ARE ALSO SHOWING SIGNS OF ROUNDING OUT ON THE CONNECTION END. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247577 ↗
• MalfunctionJan 5, 2021Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117529 ↗
• 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 11046291 ↗
• 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 11027895 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING CASE REAMER AND FED ADB SHAFT WOULD NOT STAY ON HUDSON ADAPTER LOOKS LIKE END OF REAMER AND SHAFT ARE ROUNDED OUT AND ADAPTER STRIPPED. A SURGICAL DELAY OF THIRTY SECONDS.

  Patient problems: No Code Available

  MAUDE report 10542790 ↗
• MalfunctionMar 27, 2020Break; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Break; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS ARE WORN OR BROKEN. NO LONGER WORKING CORRECTLY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889020 ↗
• MalfunctionFeb 12, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE 18 TC3 REAMER WILL NOT STAY ON THE MBT REVISION ATTACHMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701987 ↗
• MalfunctionFeb 11, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695068 ↗
• MalfunctionOct 29, 2019Fitting Problem; Device-Device Incompatibility; Fitting Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER WILL NOT STAY IN REAMER ADAPTER. IT FALLS OFF WHEN REAMING DEEP INTO THE CANAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249786 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WON'T LOCK ON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241197 ↗
• 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 9151660 ↗
• 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 9151658 ↗
• MalfunctionSep 17, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMERS, T-HANDLE, AND ADAPTORS CONNECTIONS ARE WORN. THE WRENCH WAS BENT. THE VIEW PLATE WAS CRACKED INTO TWO PIECES AND ALL INSTRUMENTS NEEDS REPLACEMENT. THESE ARE ALL OUT OF OFFICE SETS REPLACED TO (B)(6) OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075876 ↗
• MalfunctionJul 17, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT HUDSON/REAMERS WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799886 ↗
• MalfunctionMay 30, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMER WAS STRIPPED AND WONT WORK ON THE ADAPTER. ALL PIECES ARE BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8653616 ↗
• MalfunctionMar 25, 2019Break; Material Deformation; Material Twisted/Bent; Naturally Worn; Break; Material Deformation; Material Twisted/Bent; Naturally Worn

  TOTAL KNEE REVISION. CASE WAS NOT EXPLANTING A DEPUY IMPLANT. WHILE REAMING, SOME OF THE REAMERS WERE BREAKING FREE FROM THE HUDSON ADAPTER WHERE THEY WERE NOT ABLE TO FULLY ENGAGE THE CORTICES. THERE WAS A FIVE MINUTE DELAY DUE TO DIFFICULTY REAMING. FLAGGED BROKEN INSTRUMENTS AND OPENED ANOTHER SET TO CONTINUE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. ONCE PROCESSED THROUGH SPD, MULTIPLE REAMERS (16,17,18,19,20,22) WERE NOTICED TO HAVE ROUNDED ENDS WHERE IT ATTACHED TO THE HUDSON ADAPTOR. IT WAS ALSO NOTICED THAT BOTH HUDSON ADAPTORS AND T-HANDLES HAVE WORN HUDSON ADAPTORS.

  Patient problems: Not Applicable

  MAUDE report 8447859 ↗
• MalfunctionFeb 15, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT THE SIZE 10-18 MBT REVISION REAMERS ARE DULL AND SKIPPING ON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345073 ↗