ATTUNE 2506-10-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295436225), received between May 30, 2019 and Jun 9, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE FEMORAL TRIAL THAT HAS A CRACK AT THE NOTCH. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099434 ↗
• MalfunctionMar 6, 2023Break; Break

  IT WAS REPORTED THAT THE PEG WAS BROKEN AND STUCK IN BOTTOM SLOT. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488008 ↗
• MalfunctionAug 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PINS WON¿T GO THRU TIBIA BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192460 ↗
• MalfunctionMay 31, 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 14548529 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED THAT THE DOCTOR WAS PUTTING IN A FIXATION PIN AND THE PIN BROKE OFF INSIDE THE TIBIA CUTTING GUIDE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468147 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ATTUNE REVISION TIBIAL BLOCK L HAS BURR IN SCREW HOLE. NEEDS REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681345 ↗
• MalfunctionApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT "THE FIXATION PIN GOT STUCK IN ONE OF THE PIN HOLES. IT IS STILL IN THE PIN HOLE. NO FURTHER INFORMATION IS AVAILABLE." NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671285 ↗
• MalfunctionOct 6, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PRODUCT AND LOT NUMBER RECEIVED FOR THE FIXATION PIN. THE REPORTED EVENT CAUSED A 3-MINUTE DELAY TO SURGERY. ONE PIN IS RETURNING ALONG WITH THE BLOCK. REP ALSO CONFIRMS THAT NO INSTRUMENT WAS BROKEN INTO TWO OR MORE PIECES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10639073 ↗
• MalfunctionMay 30, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  LEFT TIBIAL CUTTING BLOCK WAS DAMAGED IN CASE. RESIDENT PINED TIBIAL CUTTING BLOCK WITH PIN AND STARTED THE DRILLING AT AN ANGLE. THIS STRIPPED THE PIN AND JAMMED IT IN ONE OF THE PIN HOLES LOCATED ON THE CUTTING BLOCK. THIS ADDED ROUGHLY 2-3 MINUTES TO THE CASE. THEY WERE UNABLE TO REMOVE THE PIN FROM THE CUTTING BLOCK AFTER THE CUT HAD BEEN MADE. THEY WERE EVENTUALLY ABLE TO TWIST THE BLOCK AND PIN OUT OF THE PATIENT. AN INSERT HANDLE AND INSERT WERE DAMAGED IN THE CASE. THE SURGEON MADE A CLEAN UP CUT WITH INSERT AND HANDLE IN PLACE. BOTH THE INSERT AND INSERT HANDLE WERE DAMAGED AND TAGGED.

  Patient problems: Not Applicable

  MAUDE report 8653644 ↗