NA 2178-63-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295096375), received between Jul 27, 2017 and Apr 23, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 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.

• 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 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 21889833 ↗
• MalfunctionMar 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SURGEON TRIED TO REMOVE THE REAMER AND IT CONTINUED TO DISCONNECT FROM THE T HANDLE. ANOTHER T HANDLE WAS USED TO CHECK AND IT WAS DEFINITELY THE REAMER THAT WAS THE ISSUE AND NEITHER T HANDLE WAS GRIPPING WHEN THE REAMER WAS PUT UNDER TORQUE..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632814 ↗
• MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825445 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE 20 MM REAMER WOULD "SLIP" ON BOTH T- HANDLE AND REAMER ADAPTER DURING CASE. EDGES APPEAR TO BE ROUNDED UPON INSPECTION AFTER SURGERY. REMOVED FROM SET AND NEEDS TO BE REPLACED. THERE WAS 1 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 11769300 ↗
• 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 11117548 ↗
• 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 11057583 ↗
• 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 11046292 ↗
• MalfunctionNov 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DISTAL FEMORAL JIG WOULD NOT SLIDE OVER THE 20 MM REVISION REAMER. WE TRIED ALL THE OTHER REAMERS AND THEY WORKED SO IT HAS TO BE THE 20 MM REVISION REAMER. A SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 10868935 ↗
• 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 9889039 ↗
• 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 9695069 ↗
• 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 9129115 ↗
• 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 8447865 ↗
• 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 8124385 ↗
• MalfunctionOct 12, 2018Connection Problem; Connection Problem

  THE CONNECTION BETWEEN THE REAMER (SIZE 20) AND THE MODIFIED HUDSON ADAPTOR IN THE MBT REVISION SET KEPT COMING APART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960220 ↗
• MalfunctionMay 14, 2018Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REAMERS HAVE STRIPPED FROM USE . NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7510182 ↗
• MalfunctionApr 16, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE REAMER ATTACHMENT PART TO POWER IS STRIPPED AND FRAYED AND WILL NO LONGER CONNECT TO POWER EQUIPMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432775 ↗
• 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 7356870 ↗
• MalfunctionMar 15, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS NEED A REPAIR. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341075 ↗
• MalfunctionDec 12, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE REAMER WAS DAMAGED AND WILL NOT STAY ON ADAPTER. IT WAS ALSO REPORTED THAT THE T HANDLE CONNECTION WAS DAMAGED DUE TO REAMER BEING ROUNDED OFF AT CONNECTION POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108488 ↗
• MalfunctionNov 15, 2017Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS. / / INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (4) 217863136 MODIFIED HUDSON ADAPTER, LOT NUMBERS TBPKE, H0609, AND TBLTW. THE REMAINING REPORTED 217863136 MODIFIED HUDSON ADAPTER WERE NOT RECEIVED FOR EXAMINATION. EXAMINATION OF THE FOUR SUBMITTED ADAPTERS CONFIRMED THE CONNECTION FEATURES THAT ATTACH TO THE REAMER ARE WORN/DAMAGED. THE DAMAGE IS CONSISTENT WITH THE REAMERS MATING FEATURE STRIPPING AFTER BEING SUBJECTED TO HARD CORTICAL BONE AND HEAVY USAGE CAUSING DAMAGE/WEAR TO THE ADAPTER. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE INVESTIGATION'S DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING, NO CORRECTIVE ACTION IS BEING PURSUED. CONTINUE TO MONITOR VIA SEP-419. / / INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7034509 ↗
• MalfunctionNov 15, 2017Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS. / / INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (4) 217863136 MODIFIED HUDSON ADAPTER, LOT NUMBERS TBPKE, H0609, AND TBLTW. THE REMAINING REPORTED 217863136 MODIFIED HUDSON ADAPTER WERE NOT RECEIVED FOR EXAMINATION. EXAMINATION OF THE FOUR SUBMITTED ADAPTERS CONFIRMED THE CONNECTION FEATURES THAT ATTACH TO THE REAMER ARE WORN/DAMAGED. THE DAMAGE IS CONSISTENT WITH THE REAMERS MATING FEATURE STRIPPING AFTER BEING SUBJECTED TO HARD CORTICAL BONE AND HEAVY USAGE CAUSING DAMAGE/WEAR TO THE ADAPTER. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE INVESTIGATION'S DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING, NO CORRECTIVE ACTION IS BEING PURSUED. CONTINUE TO MONITOR VIA SEP-419. / / INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7034483 ↗
• 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 6746568 ↗