NA 2178-63-182Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295096399), received between Jul 27, 2017 and Dec 22, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE 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 WAS BROKEN 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 11057648 ↗
• 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 9129149 ↗
• 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 8447867 ↗
• MalfunctionDec 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TOP OF THE REAMERS WERE ROUNDED OUT AND WOULD NOT STAY LOCKED IN THE HUDSON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124417 ↗
• MalfunctionSep 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REAMER IS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872281 ↗
• MalfunctionJul 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION REAMER FAILED TO STAY ATTACHED TO REAMER HANDLES OR HUDSON END. REAMER APPEAR TO BE ROUND OFF AND WILL NOT TURN WHEN ENGAGED WITH POWER REAMER OR WITH HAND REAMER. TIPS APPEAR TO BE WORN.

  Patient problems: No Information

  MAUDE report 6746569 ↗