ATTUNE 2545-00-672Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10603295133544), received between Oct 11, 2017 and Sep 10, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719336 ↗
• MalfunctionSep 10, 2026Break

  It was reported that the peg on the bottom of the size 4 RP trial chipped off. The 6mm shim cracked in half.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718344 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT THE SHIM DEVICES WERE BROKEN, THE ALIGNMENT ROD WAS BENT AND THE TRIAL POST DEVICES WERE CRACKED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. THERE WAS NO PATIENT OR USER HARM. THERE WERE NO REPORTS OF SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351292 ↗
• MalfunctionMay 12, 2026Crack

  IT WAS REPORTED THAT ITEMS WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149830 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT THERE WERE BROKEN TRIAL SHIMS, BENT ALIGNMENT ROD, CRACKED TRIAL POST.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096230 ↗
• MalfunctionApr 8, 2026Break

  WESTMORLAND GENERAL HOSPITAL HAS REPORTED TO US THAT YESTERDAY, WHILE PERFORMING A KNEE REPLACEMENT, ONE OF THE ATTUNE TRIAL INSERTS WAS SNAPPED INTO TWO PIECES. NO PATIENT HARM. ALL PIECES WERE RETRIEVED AND DISPOSED BY THE NURSE DURING THE OPERATION. NO DELAYS. NO X-RAYS. LOT NUMBER: NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823173 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIALS WERE BROKEN WHEN THE SCRUB TECH WAS TAKING THEM APART FOR CLEANING. IT WAS REPORTED THAT ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO DELAY IN THE PROCEDURE, AND NO IMPACT TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229505 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE THE SIZE 8/7 6 MM SHIM BROKE IN HALF AND SIZE 8 RP ARTIC SURF ALSO BROKE. MOST PIECES INCLUDING SPRINGS WERE RECOVERED AND THE SURGEON WAS CONFIDENT THAT NOTHING WAS LEFT IN THE JOINT AFTER SPENDING APPROXIMATELY FIVE MINUTES RETRIEVING FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036399 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438371 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438332 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438317 ↗
• MalfunctionAug 18, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED THAT SHIMS WERE CRACKED AND DAMAGED. THE PRODUCT DAMAGE DOCUMENTED WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833127 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THE TRAILING PROCESS THE POLY TRIAL WAS REMOVED IN A FORCEABLE WAY AND BOTH THE ARTICULAR SURFACE AND THE SHIM ATTACHED WERE BROKEN. THE ARTICULAR SURFACE WAS BROKEN INTO TWO PIECES, BOTH PIECES WERE RECOVERED FROM THE FIELD. THE SHIM WAS ALSO BROKEN INTO TWO HALF PIECES AND BOTH WERE RECOVERED. AFTER THESE PIECES WERE REMOVED NO FURTHER TRAILING WAS NEEDED, SO THIS INCIDENT DID NOT EXTEND SURGICAL TIME AND NO CONCERNS WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774803 ↗
• MalfunctionAug 18, 2024Break; Break

  IT WAS REPORTED THAT THE SHIM AND ARTICULATING SURFACE FROM ATTUNE ARE BROKEN. PATIENT NOT AFFECTED 3 MINUTE DELAY FOR NEW TRAY LUG SHEARD ON SURFACE AND SHIM BROKE IN 2 PIECES WHEN REMOVED FROM A TIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999198 ↗
• MalfunctionJun 21, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE ITEM IS CHIPPED AND OUTER EDGES ARE DAMAGED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583121 ↗
• MalfunctionMay 21, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: 1. NO PATIENT HARM DURING THE CASE AS A RESULT OF THE INSERT BREAKING. 2. SURGERY WAS NOT DELAYED. 3. INSTRUMENT BROKE INTO 2 PIECES AND THE PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358234 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THAT THE SHIM TRIALS BROKE DURING REMOVAL, ALL PIECES RETRIEVED AND ACCOUNTED FOR, NO DELAYS TO SURGERY OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243424 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT THE RP SHIM BROKE DURING TRIAL REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290263 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950935 ↗
• MalfunctionSep 28, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE TRAILING DUE TO INCORRECT USE. PATIENT IMPACT ¿ DELAY IN SURGERY AS WE HAD TO WAIT TO OPEN ANOTHER INSTRUMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835487 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED THAT SMALL PIECES BROKE OFF THE SHIM DURING CLEANING PROCESS. SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798184 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT INSTRUMENT IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070290 ↗
• MalfunctionApr 5, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT ALL ITEMS WERE CRACKED, BROKEN AND STICKING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681767 ↗
• MalfunctionApr 3, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE ALL ITEMS WERE CRACKED, BROKEN OR STICKING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664487 ↗
• MalfunctionApr 3, 2023Break; Crack; Scratched Material; Break; Crack; Scratched Material

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663964 ↗