NA 2178-63-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 281 adverse event reports that list this exact device (DI 10603295096252), received between Jul 17, 2017 and Jul 10, 2025 — classified as 281 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (91 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 281 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22471005 ↗
• MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HUDSON ADAPTOR RELEASED WHEN THE DOCTOR PUT ANY BACKPRESSURE ON THE REAMER DURING A TOTAL KNEE ARTHROPLASTY (TKA). THERE WAS NO LOSS OF TIME OR ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373500 ↗
• MalfunctionApr 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PREPARATION OF THE FEMORAL STEM, THE REAMER ADAPTER AND 20 MM REAMER BEGAN TO SLIP AT THE CONNECTION BETWEEN THE TWO. UPON INSPECTION AFTER THE CASE, BOTH SHOW SIGNS OF WEAR AND SHOULD BE REPLACED. ADDITIONALLY, THE RP ATTUNE TIBIAL IMPACTOR BROKE WHILE IMPLANTING THE THE TIBIAL TRAY. THIS SPLIT INTO 2 PIECES AND NO PIECES WERE LEFT IN THE PATIENT. THIS CAUSED A 30 SECOND DELAY AND HAD NO ILL EFFECT ON THE PATIENT OR OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889832 ↗
• MalfunctionFeb 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON PERFORMED A PRIMARY KNEE CASE USING THE ATTUNE REVISION AND NOILES SROM HINGE. THE BROACH REAM CONNECTION AND MODIFIED HUDSON INSTRUMENTS WERE NOT ABLE TO TURN AND CUT INTO THE FEMUR. THERE WAS A 10 MINUTE DELAY TO THE CASE, AND THE SURGEON CARRIED ON WITH THE PROCEDURE NO OTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396769 ↗
• MalfunctionJan 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T-HANDLE AND HUDSON ADAPTOR DID NOT CONNECT PROPERLY TO REAMERS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162192 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T-HANDLE AND HUDSON ADAPTOR DO NOT CONNECT PROPERLY TO REAMERS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162180 ↗
• MalfunctionOct 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE ADAPTOR IS NO LONGER GRIPPING THE REAMERS AT THE CONNECTION POINT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461950 ↗
• MalfunctionJun 21, 2024Break; Break

  BROKEN MBT HUDSON ADAPTOR X2 WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-02080351 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583324 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT 2) MBT HUDSON ADAPTORS ARE BROKEN. NO SURGERY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583300 ↗
• MalfunctionMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTER IS STRIPPED. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260228 ↗
• MalfunctionApr 29, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTOR IS STRIPPED AND NO LONGER WORKS.

  Patient problems: Insufficient Information

  MAUDE report 19200520 ↗
• 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 18777755 ↗
• 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 18777744 ↗
• 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 18777739 ↗
• 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 18777680 ↗
• 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 18229860 ↗
• MalfunctionAug 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 REAMER ADAPTER AND T HANDLE WERE WORN. THE INCIDENT CAUSED AT LEAST 15-20MINUTES DELAY TO THE SURGERY AS THE SURGEON HAD DIFFICULTY USING AND PROGRESSING THE REAMERS, DOWN THE TIBIA AND UP THE FEMUR. THERE WAS NO OVERALL DETRIMENTAL EFFECT TO THE SURGERY FOR THE PATIENT AND THE END OUTCOME WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 17550671 ↗
• MalfunctionAug 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 REAMER ADAPTER AND T HANDLE WERE WORN. THE INCIDENT CAUSED AT LEAST 15-20MINUTES DELAY TO THE SURGERY AS THE SURGEON HAD DIFFICULTY USING AND PROGRESSING THE REAMERS, DOWN THE TIBIA AND UP THE FEMUR. THERE WAS NO OVERALL DETRIMENTAL EFFECT TO THE SURGERY FOR THE PATIENT AND THE END OUTCOME WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 17550659 ↗
• MalfunctionJul 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTOR END OF THE HUDSON HAD STRIPPED. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344884 ↗
• MalfunctionJul 18, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTOR HAS ¿ROUNDED OFF¿ FROM LONG TERM USE. THIS MEANS THAT THEY OFTEN DISCONNECT DURING USE AND THE REAMERS CAN BECOME STUCK AS THEY JUST SPIN IN THE MECHANISM AND CAN¿T LOCK IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341174 ↗
• MalfunctionMay 31, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HUDSON ADAPTOR WAS STRIPPED NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032584 ↗
• MalfunctionMay 4, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CHUCK END HAS ROUNDED OFF WITH LONG TERM USE, MAKES REMOVING FROM ATTACHMENTS VERY DIFFICULT AND INTRAMEDULLARY REAMERS SPIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867759 ↗
• 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 16637493 ↗
• 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 16590877 ↗
• 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 16590870 ↗