NA 2178-63-199Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295096535), received between Jul 18, 2017 and Feb 26, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 18777723 ↗
• 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 18777667 ↗
• MalfunctionAug 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS WOULD NOT STAY PROPERLY CONNECTED TO HUDSON ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637336 ↗
• MalfunctionAug 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS WOULD NOT STAY PROPERLY CONNECTED TO HUDSON ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17636719 ↗
• MalfunctionDec 14, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DRILL IS ROUNDED ON ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983613 ↗
• MalfunctionAug 9, 2022Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LCS COMPONENTS ARE NOT ENGAGING PROPERLY. THE END OF BROACH INSERTER IS CRACKED. THE BACK END OF DEPTH GAUGE KEEPS FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191225 ↗
• MalfunctionMay 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO REAMER CHUCKS STRIPPED OUR AND THE CONE REAMER IS STRIPPED. NEEDS REPLACED. DELAYED PROGRESS OF CASE BECAUSE IT KEPT STRIPPING. A SURGICAL DELAY OF 10 MINUTES WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 11833206 ↗
• MalfunctionMar 15, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488202 ↗
• 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 11172821 ↗
• 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 11057383 ↗
• 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 10535491 ↗
• MalfunctionJul 15, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PRIMARY CONICAL MBT REAMER STRIPPED OUT AND WOULD SPIN INSIDE THE HUDSON ADAPTER. SURGICAL DELAY 2 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 8790597 ↗
• MalfunctionJun 25, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE MODIFIED HUDSON ADAPTER AND T HANDLE REPEATEDLY SLIPPED WHEN REAMING THE TIBIA AND FEMUR DURING REVISION TOTAL KNEE.

  Patient problems: Not Applicable

  MAUDE report 8730661 ↗
• MalfunctionMar 8, 2019Material Deformation; Material Deformation

  THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. OFFICE SET, DID NOT AFFECT SURGERY OR PATIENT. EXAMINATION OF THE RETURNED PRODUCT BY THE PRODUCT ANALYST DETERMINED THAT THE LOCKING FEATURE APPEARED TO BE STRIPPED, PREVENTING PROPER FUNCTIONALITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405003 ↗
• 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 8331005 ↗
• MalfunctionDec 27, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMER AND THE REAMER ADAPTER CONNECTIONS ARE WORN AND NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200306 ↗
• MalfunctionDec 20, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TOP OF THE REAMERS WERE WORN AND WOULD NOT LOCK INTO HUDSON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185549 ↗
• MalfunctionOct 11, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 3 AND 4 SIGMA REV TIBIA TRIAL TRAYS WERE NOT ENGAGING WITH THE STEM TRIALS. WHILE PREPARING THE TIBIA THAT HUDSON ADAPTER WAS NOT ENGAGING THE PRIMARY CONICAL REAMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955443 ↗
• MalfunctionMar 21, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON WAS REAMING THE TIBIA AND THE MBT REVISION REAMERS WERE SPINNING INSIDE THE MODIFIED HUDSON ADAPTER CONNECTION AND T-HANDLE CONNECTION. THIS REQUIRED HAVING TO USE SEVERAL DIFFERENT HUDSON ADAPTERS TO COMPLETE THE REAMING. AS A RESULT, THE REAMERS AND ADAPTERS ARE NO LONGER FUNCTIONING CORRECTLY. THERE WERE NO PIECES BROKEN OFF OF ANY OF THE INSTRUMENTS AND NO ADVERSE AFFECT TO THE PATIENT AND THE SURGEON DOES NOT WANT TO BE CONTACTED. THERE IS NO FURTHER INFORMATION AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357348 ↗
• MalfunctionNov 28, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONNECTION SIDE OF THE MBT REV PRIMARY REAMER WAS STRIPPED AND NEEDS TO BE REPLACED. IT WOULD NOT STAY CONNECTED TO THE ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7063822 ↗
• MalfunctionJul 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE REAMING FOR A MBT REVISION TRAY, THE PRIMARY CONICAL REAMER AND THE MODIFIED HUDSON ADAPTER STRIPPED OUT AND WOULD SPIN.

  Patient problems: No Information

  MAUDE report 6722203 ↗
• MalfunctionJul 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE REAMING FOR A MBT REVISION TRAY, THE PRIMARY CONICAL REAMER AND THE MODIFIED HUDSON ADAPTER STRIPPED OUT AND WOULD SPIN.

  Patient problems: No Information

  MAUDE report 6722178 ↗