ATTUNE 2506-20-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295440567), received between Feb 20, 2018 and Jul 1, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646207 ↗
• MalfunctionMar 5, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHEN REAMING THROUGH THE TIBIA PREP TOWER, THE TIBIA BOSS REAMER BOUND UP IN THE TOWER. IT WAS NOTED AFTER THE CASE THAT THE REAMER HAD BECOME DEFORMED DUE TO RIFLING AND IS NO LONGER USEABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837006 ↗
• MalfunctionOct 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? ONLY A FEW MINUTES WHY WE WERE TRYING TO WORK OUT WHY THEY WERE UNABLE TO REMOVE THE REAMER. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965921 ↗
• MalfunctionDec 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COMICAL REAMER GOT BOUND UP IN THE TOWER. IT WOULD NOT REAM AS IT WAS STUCK IN THE TOWER. THE TOWER HAD TO BE MALLETED OFF OF THE REAMER. THERE WAS A SURGICAL DELAY WHILE RETRIEVING A NEW INSTRUMENT TRAY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 15894312 ↗
• MalfunctionDec 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COMICAL REAMER GOT BOUND UP IN THE TOWER. IT WOULD NOT REAM AS IT WAS STUCK IN THE TOWER. THE TOWER HAD TO BE MALLETED OFF OF THE REAMER. SURGICAL TIME WAS DELAYED TO RETRIEVE A NEW TRAY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15894163 ↗
• MalfunctionAug 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE HOSPITAL HAVE REPORTED DIRTY INSTRUMENTS ON THE ATTUNE REVISION SET. 2 SOILED INSTRUMENTS WITHIN THE GENERAL INSTRUMENTS, HOSPITAL HAVE CLEANED AND PROCESSED THEM ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209565 ↗
• MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STERILE SERVICES IDENTIFIED MULTIPLE INSTRUMENTS WITH RED RESIDUE PRESENT, MAINLY AFFECTING TIBIAL TRIALS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443985 ↗
• MalfunctionDec 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS AN ATTUNE TKR CASE DONE IN MEH 28/11, WITH THE FOLLOWING IMPLANTS USED: THE PREPARATION OF PRIMARY KNEE INSTRUMENTS WAS DONE ACCORDINGLY AND AS PER PLANNED. FEMUR CUTS PROCEEDED AS PER NORMAL, WHEN PROCEEDING TO TIBIA PREPARATION, DR ASKED FOR SHORT CEMENTED TIBIA 14X50MM STEM AND WE GOT THE INSTRUMENTS READY. HE DRILLED FOR THE STEM, THEN ATTACH THE STEM TRIAL TO THE FAT REAMER (FOR THE CONE). JUST WHEN HE WAS ABOUT TO DO THE KEEL PUNCH, THE INSTRUMENT FELL ONTO THE GROUND. HE THEN CHECKED WITH DR WHO DECIDED TO PREPARE THE KEEL AS PER PRIMARY TRAY. UPON PREPARING AS PER PRIMARY TRAY, HE FOLLOWED THROUGH THE TRIAL WITH THE PRIMARY TRAY TRIAL CONSTRUCT AND DECIDED ON THE IMPLANTS TO BE USED. DESPITE NOT TRIALLING WITH THE STEM, DR ASKED FOR THE STEM IMPLANT AND DECIDED TO IMPLANT WITH IT AS THE PREPARATION WAS ALREADY MADE. WHILE CEMENTING AND IMPLANTING THE TIBIA, HE EXPERIENCED SOME RESISTANCE AND MANAGED TO IMPACT AND IMPLANT THE TIBIA WITH STEM SUCCESSFULLY. UPON CLOSURE, OUR REPS CLEARED THE INSTRUMENTS WHICH WERE ALL LEFT IN THE BASIN BY THE OT SCRUB NURSE AND REALISED THE STEM TRIAL WHICH WAS ORIGINALLY TIGHTLY SCREWED ONTO THE FAT CONICAL REAMER WAS MISSING AND AL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491271 ↗
• MalfunctionNov 4, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE CONICAL DRILLS WERE GETTING HUNG UP IN THE TOP OF THE DRILL TOWERS AND NOT PASSING THROUGH SMOOTHLY. THE SURGEON QUESTIONED WETHER ANY OF THE PRODUCTS WERE DAMAGED OR DEFECTIVE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272970 ↗
• MalfunctionNov 4, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE CONICAL DRILLS WERE GETTING HUNG UP IN THE TOP OF THE DRILL TOWERS AND NOT PASSING THROUGH SMOOTHLY. THE SURGEON QUESTIONED WETHER ANY OF THE PRODUCTS WERE DAMAGED OR DEFECTIVE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272965 ↗
• MalfunctionOct 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL WILL NO LONGER FIT INTO THE TOWER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193585 ↗
• MalfunctionApr 8, 2019Peeled/Delaminated; Mechanical Jam; Scratched Material; Peeled/Delaminated; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE BLADE OF THE TIBIAL CEMENTED CONICAL REAMER (P/N: 250620103) WAS CAUGHT IN THE SRI ATTUNE STEMABLE TIBIA TOWER (MANUFACTURED BY KSI) AND IT WAS STUCK AND THE FIXED TIBIA PLATE WAS COME OFF DURING TKA SURGERY ON (B)(6) 2019. THE SURGEON RE-PLACED IT AND REPEATED THE SAME PROCESS. HOWEVER, THE BLADE AND TOWER WERE SCRAPED, AND THE METAL POWDER WAS APPEARED. THUS, THE SURGEON STOPPED USING THE INSTRUMENTS TO PREVENT HEALTH DAMAGE TO THE PATIENT. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. IT SEEMED TO BE AN ISSUE OF ACCURACY OF THE TIBIA TOWER AND THE CONICAL REAMER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 8492459 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED THAT THE ATTUNE REVISION FB TIBIAL DRILL BIT HAS BURRS ON IT, WHICH HAS SCORED THE INSIDE OF THE DRILL TOWER. PLUNGING THE DRILL BIT INTO THE DRILL TOWER PRODUCES SMALL METAL SHAVINGS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196904 ↗
• MalfunctionDec 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TOWER AND REAMER WERE ENGAGED IMPROPERLY AND THIS CAUSED THE DRILL AND TOWER TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8163801 ↗
• MalfunctionJun 29, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DRILL AND TOWER BIND TOGETHER AND GOT STUCK. CONTINUE TO GET STUCK WHEN UNDER COVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650383 ↗
• MalfunctionJun 29, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON REPORTED THAT PREPARING THE TIBIAL TRAYS HE NOTED A POOR ADHESION/COMPLIANCE BEETWEN THE TIBIAL COMPONENTS. THEY MATCH SO WELL THAT THE MOVEMENTS ARE LIMITED. THE INTERVENTION WAS CONCLUDED USING THE CLAIMED PRODUCTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650213 ↗
• MalfunctionFeb 20, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE REAMER BINDED INSIDE DRILL TOWER AND WOULD NOT ADVANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7283320 ↗