ATTUNE 252303203Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295437130), received between Aug 5, 2019 and Aug 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Corroded” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING A WORKSHOP IT WAS NOT POSSIBLE TO PROPERLY FIX THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. IT SEEMS THAT SOMETHING IS WRONG WITH THE TREADS OF THE TRIAL. THEY ARE SOMEHOW COLD WELDED. THE INSTRUMENTS WERE DIFFICULT TO SCREW TOGETHER AND STOPPED WORKING BEFORE THEY ARE FIRMLY CONNECTED. AT THIS POINT, THE ITEMS COULD NO LONGER BE UNSCREWED. (B)(4) IS RELATED TO (B)(4) 10 IPS (B)(4) 5 IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861169 ↗
• MalfunctionApr 3, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT TARNISHING WAS FOUND ON THE INSIDE OF THE TRIALS. IT WAS UNABLE TO BE REMOVED WITH CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764893 ↗
• MalfunctionJun 28, 2024Corroded; Corroded

  THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638051 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996596 ↗
• MalfunctionOct 25, 2023Corroded; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Corroded; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE FEMORAL TRIAL HAS STARTED TO RUST DUE TO INCORRECT DETERGENT USED AT THE HOSPITAL. PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(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.: TRU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007488 ↗
• MalfunctionSep 29, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICES ARE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508404 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001448 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799829 ↗
• 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 12443946 ↗
• MalfunctionAug 20, 2019Corroded; Corroded

  WE SENT OUR NEW ATTUNE REVISION SETS AT THE FIRST TIME TO THE CUSTOMER AND GET THEM BACK WITH SOME RUSTED AREAS. WE DON´T EXACTLY KNOW WHEN THE INCIDENT OCCURED. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910344 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4). INSTRUMENTS WILL NOT BE RETURNING AS THEY WILL BE CLEANED VIA OUR REFURBISHMENT PROCESS. FOLLOWING: TV-WI-00597 ANZ SURFACE FINISH. TV-WI-00607 ANZ WI-DP-54 PASSIVATING AN INSTRUMENT. TV-SOP-00897 ANZ CLEANING DEPUY SYNTHES INSTRUMENTS. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. CASE LOGGED TO CAPTURE ALL INSTRUMENTS (TOTAL OF 39 INSTRUMENTS): 10 X INSTRUMENTS = (B)(4). 10 X INSTRUMENTS = (B)(4). 10 X INSTRUMENTS = (B)(4). 9 X INSTRUMENTS = (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861933 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861932 ↗