ATTUNE 2504-40-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295438267), received between Oct 7, 2019 and Sep 22, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THERE WAS NO SURGICAL DELAY. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? THE PATIENT WAS NOT AFFECTED. C. PLEASE CONFIRM IF THE BOLT WAS STRIPPED OR NOT. THE BOLT WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798037 ↗
• MalfunctionOct 1, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED AND NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562610 ↗
• MalfunctionAug 10, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SET SCREW ON THE BROACH ADAPTER IS DAMAGED AND WILL NO LONGER STAY IN PLACE. THREADS ON THE STEM TRIAL ARE STRIPPED AND WILL NO LONGER ATTACH TO BROACH OR BOSS ADAPTER. THIS DID NOT OCCUR DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302100 ↗
• MalfunctionApr 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ON THE BROACH ADAPTER WERE STRIPPED. A REPLACEMENT IS NEEDED TO BE SENT TO THE CHARLESTON WAREHOUSE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685725 ↗
• MalfunctionJan 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW THREADS ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123043 ↗
• MalfunctionAug 4, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS OF THE BROACH ADAPTER ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364321 ↗
• MalfunctionJul 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS WAS STRIPPED. NEEDS REPLACING. NO SURGICAL DELAY. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED.

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

  MAUDE report 10321415 ↗
• MalfunctionJun 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ATTUNE REV BROACH ADAPTOR WAS CROSS-THREADED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213514 ↗
• MalfunctionOct 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN ATTACHING THE ATTUNE REVISION FEMORAL BROACH ADAPTOR IT WOULDN¿T FULLY LOCK IN WHEN USING THE SCREWDRIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162087 ↗