ATTUNE 2545-01-701Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295423515), received between Mar 17, 2020 and Jun 2, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (16 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE STERILE PROCESSING DEPARTMENT (SPD) WAS REQUIRING THESE WORN TRAYS BE REPLACED WITH NEW TRAY DUE TO WORN OUT PLASTIC COMING OFF THE TRAY. THERE WERE NO DELAYS AND NOTHING LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364684 ↗
• MalfunctionMay 28, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313252 ↗
• MalfunctionMar 10, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562758 ↗
• MalfunctionMar 10, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562739 ↗
• MalfunctionMar 10, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE PAINT WAS PEELING FROM TRAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559593 ↗
• MalfunctionDec 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). THE INSTRUMENTS ARE DAMAGED AND UNABLE TO BE RESTERILIZED. NO PATIENTS WERE IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871559 ↗
• MalfunctionMar 25, 2025Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ONLY 6 INSTRUMENT TRAYS ARE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686155 ↗
• MalfunctionMar 25, 2025Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ONLY 6 INSTRUMENT TRAYS ARE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686153 ↗
• MalfunctionMar 25, 2025Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ONLY 6 INSTRUMENT TRAYS ARE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686151 ↗
• MalfunctionMar 4, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY CENTRAL STERILE SERVICES DEPARTMENT (CSSD) THAT THE PLASTIC COATING IS DELAMINATING FROM METAL TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518941 ↗
• MalfunctionMar 4, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY CENTRAL STERILE SERVICES DEPARTMENT (CSSD) THAT THE PLASTIC COATING IS DELAMINATING FROM METAL TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518939 ↗
• MalfunctionNov 16, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE CASE IS STARTING TO PEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156740 ↗
• MalfunctionOct 13, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY. THE PAN HAS BROKEN PLASTIC INSIDE THAT HOLDS THE INSTRUMENTS AND THE OUTLINE OF THE INSTRUMENTS IS NO LONGER VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930260 ↗
• MalfunctionMay 1, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED DURING A TOTAL KNEE SURGERY THAT THE BLACK LABEL ON THE SIDE OF THE PRIMARY RESECTIONS TRAY WAS STARTING TO WEAR. SMALL SECTIONS OF THE LABELING HAD STARTED TO COME OFF. THIS DID NOT CAUSE ANY ISSUES WITH THIS CASE AND IT WAS COMPLETED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846914 ↗
• MalfunctionApr 26, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PAINT PLANING OFF CAUSES CONTAMINATION ISSUE FOR HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817113 ↗
• MalfunctionFeb 3, 2022Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated

  IT WAS REPORTED THAT THE INSTRUMENT CASE IS FADING OR LOOSING COLOR THIS WAS NOTICED AFTER THEY HAD STERILIZED IT, THEY COULD SEE SMALL DARK SPOTS IN THE CASE AND THE PAPER WRAPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442053 ↗
• MalfunctionJun 1, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  34 HOSPITAL CONSIGNED INSTRUMENT TRAYS THAT OVER 9 YEARS OLD ARE WORN AND BEYOND USE. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912303 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478492 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478491 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478490 ↗
• MalfunctionAug 31, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA. SO THEY REQUESTED THAT WE REPLACE THE TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10472411 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA. SO THEY REQUESTED THAT WE REPLACE THE TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285756 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA. SO THEY REQUESTED THAT WE REPLACE THE TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285702 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS NO HARM OR DELAY. ATTUNE TOTAL KNEE INSTRUMENT TRAYS WERE BEGINNING TO DELAMINATE ON THE INSIDE. THE BLACK PIECES THAT HOLD INSTRUMENTS IN PLACE WERE STARTING TO PEEL BACK. THE HOSPITAL WAS CONCERNED THAT THIS COULD CREATE A POSSIBILITY FOR HARBORING BACTERIA. SO THEY REQUESTED THAT WE REPLACE THE TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285654 ↗
• MalfunctionMar 17, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT RECENTLY THE OPERATING ROOM STAFF HAS BEEN FINDING BLACK SPECS IN THE SETS. THEY ARE VERY SMALL BLACK SPECS. THEY ASKED THE OPERATING ROOM TO SEND ME SAMPLES OF THESE BLACK SPECS. THEY WERE MOSTLY FOUND ON THE BOTTOM OF THE TRAYS INSIDE THE WRAPPERS. A FEW TIMES THEY FOUND SPECS INSIDE THE CORNER PROTECTORS THAT THEY USED. THE INSIDE WRAP WAS WHITE SO THEY ARE EASY TO IDENTIFY. WHAT THEY FOUND WAS THAT THE BLACK BUMPERS ON THE TRAYS WHICH PROVIDES PROTECTION WAS PEELING OFF. PERHAPS DURING THE TRANSPORTATION AND STACKING OF TRAYS THE BUMPER MATERIAL BREAKS DOWN. NOT SURE IF YOU HAVE RECEIVED ANY OTHER CONCERNS ABOUT THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842807 ↗