NA 96-1671Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295239772), received between Jun 22, 2017 and May 16, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THE RUBBER SEALS ON SEVERAL TRIALS WERE TORN. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036560 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  THE THREAD IN THIS REAMER IS DAMAGED AND THE ADAPTOR ROD CANNOT BE SCREWED IN TO IT. (IT REQUIRES A TAP BEING RUN THROUGH THE THREAD?) INSTRUMENT WAS PART OF A "LOAN" INSTRUMENT SET. THERE WAS A 2 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 15938806 ↗
• MalfunctionMar 15, 2021Break; Failure to Cut; Material Twisted/Bent; Break; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED THAT THE MBT SIZE 1.5 TRAY TRIAL IS CRACKED, BOTH PIECES WERE RETRIEVED FROM THE PATIENT. THE MBT REV PRIMARY REAMER IS DULL AND NEEDS TO BE REPLACED PER SURGEON REQUEST. THE TC3 BROACH REAMER IS DULL AND WORN DOWN, NEEDS TO BE REPLACED. THE SIG HP REV ADP REM SHAFT LONG IS STRIPPED AND WORN, NO PIECES BROKE OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488261 ↗
• MalfunctionJan 5, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE RUBBER PIECE INSIDE SLEEVE REAMER IS MISSING. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118497 ↗
• MalfunctionJun 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SURGERY THE REVISION ADAPTER SHAFT BECAME VERY DIFFICULT TO UNSCREW. WE WERE ABLE TO DISCONNECT IT BUT IT WILL NO LONGER THREAD IN THE REAMER. BOTH NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10114453 ↗
• MalfunctionFeb 12, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER SHAFT WOULD NOT STAY CONNECTED TO HUDSON ADAPTER OR MBT REVISION T HANDLE SHAFT THAT CONNECTS TO ADAPTER AND T HANDLE SEEMS WORN DOWN T HANDLE AND ADAPTER WHERE SHAFT OF REAMER CONNECTS TO SEEMS WORN DOWN.

  Patient problems: Not Applicable

  MAUDE report 9702075 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT WILL NOT DISASSEMBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239688 ↗
• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  STEM TRIALS CANNOT BE ATTACHED/REMOVED TO/FROM REAMER WITHOUT GREAT DIFFICULTY. OCCURRED DURING SURGERY, RESULTED IN NO DELAY. ITEM DID NOT BREAK INTO 2 OR MORE PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739861 ↗
• MalfunctionMay 22, 2019Dull, Blunt; Dull, Blunt

  THE SURGEON INDICATED THAT PREVIOUS USE OF THE PRODUCT (VERY OLD) HAD CONTRIBUTED TO IT'S MALFUNCTIONING. REASON FOR REVISION: PAIN, POSSIBLE INFECTION AND LOOSENING. DURING THE PREPARATION OF THE FEMUR FOR BROACHING, THE REAMER STOPPED TURNING AND WOULD NOT ADVANCE. UPON CLOSER EXAMINATION, THE DRILL WAS TURNING BUT THE REMOVABLE SHAFT ATTACHED TO THE REAMER WAS NOT. UPON EVEN CLOSER EXAMINATION, THE REMOVABLE SHAFT WAS NOT ENGAGING WITH THE HUDSON ADAPTER OR THE T-HANDLE. THE "LOCKING" END OF THE SHAFT IS BURRED, SQUASHED, AND NO LONGER SQUARE. THE HUDSON ADAPTER NO LONGER FUNCTIONED PROPERLY AFTER THIS INCIDENT. THE UNIVERSAL REVISION FEMORAL BROACH REAMER IS BLUNT AND NOT CUTTING BONE PROPERLY.

  Patient problems: Not Applicable

  MAUDE report 8632904 ↗
• MalfunctionJan 17, 2019Component Missing; Component Missing

  WORN INSTRUMENTS, NEED TO BE REPLACED. SOME OF THE " O RINGS" ARE MISSING FROM THE REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258570 ↗
• MalfunctionSep 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE BROACH REAMER HAS BEEN TIGHTENED TOO TIGHT INTO THE ROD. THEY WERE UNABLE TO DISASSEMBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907328 ↗
• MalfunctionMay 21, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE THREADS INSIDE BROACH REAMER ARE STRIPPED. NOTHING WILL THREAD DOWN INTO IT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7529209 ↗
• MalfunctionMay 16, 2018Break; Break

  REVISION TKR, (B)(6) HOSPITAL (B)(6) 2018. WHEN SETTING UP THE INSTRUMENTS. JNJ REPRESENTATIVE NOTICED THAT THE HUDSON ADAPTER AND THE T HANDLE WERE SPLADE AND WHEN TEST THEY DID NOT WORK. JNJ REPRESENTATIVE TESTED THE DRILL SHAFT AND BROACH REAMER AND THERE WERE SLOTS BROKEN. DUE TO NO FAULT OF THIS, THE SURGERY GOT CANCELLED. JNJ REPRESENTATIVE REPLACED THE INSTRUMENTS FOR THE RE-SCHEDULED CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7519655 ↗
• MalfunctionJun 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE REVISION BROACH REAMER AND SIGMA HP FEMORAL ADAPTER SHAFT BECAME STUCK TOGETHER AND CANNOT BE SEPARATED.

  Patient problems: No Information

  MAUDE report 6662600 ↗