SIGMA 2011-03-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295081487), received between Jun 22, 2017 and Dec 19, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break; Break

  CHIPPED AT THE PROXIMAL END. 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, (B)(4). 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 23850287 ↗
• MalfunctionApr 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THERE WAS A STRIPPED INSTRUMENT AND IT NO LONGER ATTACHES PROPERLY. MANUAL REAMERS WERE USED. SURGERY WAS DELAYED 10 MINUTES. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910949 ↗
• MalfunctionFeb 18, 2025Failure to Cut; Mechanical Jam; Failure to Cut; 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 21400862 ↗
• MalfunctionJul 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTOR TO THE HUDSON HAD STRIPPED AND WAS REMOVED FROM USE. THE EVENT DID NOT HAPPEN IN SURGERY. THERE IS NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343693 ↗
• MalfunctionApr 8, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE OUTER BLACK PLASTIC COVER ON THE DISTAL TORQUE MOUNT WAS MISSING AND THE INNER WHITE PLASTIC WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052590 ↗
• MalfunctionMar 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE SIGMA HP ADAPTOR REAMER SHAFT WAS DISCONNECTING FROM THE T-HANDLE AND REAMER SHAFT WHILE TRYING TO REMOVE THE ADAPTOR REAMER FROM THE FEMORAL CANAL DURING SURGERY. UPON INSPECTION, THE CONNECTING END OF THE REAMER SHAFT IS DAMAGED. AN ADDITIONAL REAMER WAS USED TO FINISH THE CASE. SURGICAL DELAY OF 2 MINUTES OCCURRED. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905029 ↗
• MalfunctionNov 17, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CONNECTION END OF THESE PARTS IS WORN AND NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829193 ↗
• MalfunctionJun 2, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT IT WAS A ROD THAT THREADS INTO THE SLEEVE ALLOWING A JIG TO ATTACH TO MAKE CUTS TO THE FEMUR. THE THREAD IS WORN; THIS MEAN THAT THE ROD DOES NOT ATTACH SATISFACTORILY TO THE SLEEVE/JIG. THIS MEANS THAT THE JIG CANNOT BE ATTACHED PROPERLY AND/OR RISKS BEING DISASSOCIATED MID CUT OR NOT BEING ABLE TO BE USED AT ALL. IT IS THE ROD ALONE THAT HAS WORN THREAD. NO ISSUE WITH SLEEVE OR JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920652 ↗
• MalfunctionMar 15, 2021Break; Material Twisted/Bent; Break; 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 11488267 ↗
• MalfunctionFeb 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE SURGEON INTRODUCED THE FEMORAL BOSS REAMER ON THE THREADED SHAFT INTO THE FEMORAL CANAL, THE REAMER WAS STRIPPED AT ITS CONNECTION AND COULD NO LONGER BE USED.

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

  MAUDE report 11345245 ↗
• 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 11057498 ↗
• MalfunctionNov 18, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER POST AND BROACH REAMER THREADED OUT. THIS WAS NOTICED WHEN CLEANING TRAYS UP. IT DID NOT AFFECT THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10864430 ↗
• MalfunctionJun 3, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  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 10114449 ↗
• MalfunctionMay 19, 2020Material Twisted/Bent; Material Twisted/Bent

  TWO SCREW SHAFTS STRIPPED WITH T-HANDLE AND MODIFIED ADAPTER AND NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10070648 ↗
• MalfunctionMay 19, 2020Material Twisted/Bent; Material Twisted/Bent

  TWO SCREW SHAFTS STRIPPED WITH T-HANDLE AND MODIFIED ADAPTER AND NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10070643 ↗
• MalfunctionApr 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PRODUCT 201103029 WAS STRIPPED AND WORN DOWN AT THE ATTACHMENT POINT WHERE IT WAS CONNECTED TO POWER AND WILL NOT FUNCTION PROPERLY BECAUSE OF ITS WEAR. NO PIECES BROKE OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913786 ↗
• MalfunctionMar 30, 2020Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN SPD AND WORN OUT/STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901751 ↗
• MalfunctionFeb 28, 2020Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT UPON INSPECTION DURING PROCESSING OF REVISION KNEE INSTRUMENT, IT WAS NOTICED THAT THE TIBIA TRIAL WINDOW SZ 2.5 WAS CRACKED, STEM EXTENSION WRENCH WAS HARD TO TIGHTEN, REAMER ATTACHMENT WON'T HOLD REAMER APPROPRIATELY, AND THE FEMORAL/TIBIAL/SLEEVE CLAMP APPEARS TO BE WORN DOWN. ALSO, THE REMOVABLE FEMORAL SHAFT WAS END THAT GOES INTO T-HANDLE IS GETTING STUCK ON T-HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771399 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WON'T HOLD BIT IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239721 ↗
• MalfunctionOct 7, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. THE TIBIAL TRAY IS WELL FIXED, BUT THE FEMORAL COMPONENT IS LOOSE. THE SURGEON REVISED THE FEMORAL COMPONENT AND RETAINED THE WELL-FIXED TIBIAL TRAY. DURING THE PROCEDURE, THE HUDSON ADAPTOR, FEMORAL ADAPTOR ROD, AND THE #3 TC3 BOX TRIAL BROKE OR WERE STRIPPED. ALL THE PIECES WERE PRESENT. A SURGICAL DELAY OF 1 MINUTE WAS NOTED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 9162979 ↗
• MalfunctionSep 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  UNABLE TO GET PARTS APART AFTER WASH CYCLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9010264 ↗
• 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 8730657 ↗
• MalfunctionJun 18, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIG HP REV ADP REM SHAFT LONG NEEDS REPLACING. ADP END WAS WORN AND WILL NO LONGER STAY CONNECTED TO CHUCK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707859 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  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 8632903 ↗
• MalfunctionFeb 27, 2019Device-Device Incompatibility; Material Deformation; Positioning Problem; Device-Device Incompatibility; Material Deformation; Positioning Problem

  SIGMA HP REVISION REAMER SHAFT ITEM 201103029 NOT FUNCTIONING PROPERLY. DID NOT STAY IN HUDSON ADAPTER. DELAYED SURGERY FOR 10 MINUTES. PROCEDURE COMPLETED SUCCESSFULLY WITH OTHER LIKE INSTRUMENT. NO FRAGMENTS GENERATED.

  Patient problems: Not Applicable

  MAUDE report 8374901 ↗