ATTUNE 2545-00-526Recalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 10603295132660), received between Jul 24, 2017 and Sep 25, 2026 — classified as 218 malfunctions.

The most frequently reported specific device problem is “Break” (167 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 12, 2015Class IITerminated

   Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

   Z-2138-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 218 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  It was reported that the poly trial has black mark on it that cannot be removed, Black mark on poly trial.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899829 ↗
• MalfunctionSep 22, 2026Break

  It was reported that the articulation surface trial broke a bal seal spring.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849862 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566552 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453842 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SPRING KEPT BREAKING OFF THE SHIMS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427075 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SPRING KEPT BREAKING OFF THE SHIMS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426981 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WERE A COUPLE OF LOST SPRINGS FROM ARTICULATING SURFACES IN AN ATTUNE KIT DURING SURGERIES. IT WAS ALSO NOTED THAT THE IM REAMER HAD A NOT SHARP TIP. NO IMPACT ON PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414273 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, IT WAS OBSERVED THAT THE PLASTIC TAB BROKE OFF THE TRIAL POLY. THERE NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334797 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SHIM WAS BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS A SURGERY DELAY OF AN UNSPECIFIED TIME. ALL THE PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 25284130 ↗
• MalfunctionMay 6, 2026Material Deformation

  IT WAS REPORTED THAT THE RETAINING RING WAS DAMAGED/BENT DURING DISASSEMBLY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096106 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT THE SPRINGS WERE BROKEN. THERE WAS NO CONSEQUENCES TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071734 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT ATTUNE FB CR ARTIC SURF SZ6 EXPERIENCED A SPRING BREAKAGE DUE TO WEAR AND TEAR DURING PRE-OPERATIVE HANDLING. THE DEVICE BROKE INTO TWO OR MORE PIECES, BUT THERE WAS NO HARM OR CONSEQUENCE TO THE PATIENT, AND NO DELAY TO THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788665 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT ARTICULATING SURFACE LEG WAS BROKEN. DEVICE BROKE INTO 2 PIECES AND ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604665 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION THE FOLLOWING ISSUES WERE IDENTIFIED: T-HANDLE IS CRACKED. FB TIBIAL IMPACTOR PLASTIC TOP CHIPPED OFF. TRIALS MISSING A SPRING. EXTRACTOR HAS A WORN TIP. REAMER DOES NOT STAY ON THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567610 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION THE FOLLOWING ISSUES WERE IDENTIFIED: T-HANDLE IS CRACKED, FB TIBIAL IMPACTOR PLASTIC TOP CHIPPED OFF, TRIALS MISSING A SPRING, EXTRACTOR HAS A WORN TIP, REAMER DOES NOT STAY ON THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567575 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT THE SPRING BROKEN OFF DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24522370 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE SPRING AND PLASTIC PIECE WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498017 ↗
• MalfunctionFeb 24, 2026Break; Material Deformation

  IT WAS REPORTED THAT AN ATTUNE FB CR ARTIC SURF SZ6 ARTICULATING SURFACE INSTRUMENT BROKE. THE SPRING BUCKLED AND WAS LOOSE. THERE WERE NO DELAYS WITH THE SURGERY. NOTHING WAS LEFT INSIDE THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430447 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING IS MISSING OFF THE BACK AND SURGEONS ARE COMPLAINING IT DOESN¿T SIT PROPERLY WITH THE SHIMS. PATIENT WAS NOT IMPACTED DURING SURGERY, PROCEDURE WAS CARRIED OUT WITH NO DELAY. NO MISSING PIECES LEFT IN THE PATIENT. NO HARM CAUSED. SPRING WAS NOTICED PRIOR TO SURGERY, MUST HAVE OCCURRED DURING STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399959 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT THE SPRING WAS BROKEN ON SIZE 6 ARTIC SURF TRIAL DEVICE. IT WAS REPORTED THAT THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097027 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SPRING WAS FOUND MISSING BY ¿SSD¿. THERE WERE NO PATIENT CONSEQUENCES AND NO SURGICAL DELAYS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854089 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING OF THE ARCTIC SURF WENT OFF. NO PATIENT AFFECTED OR SURGERY DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804808 ↗
• MalfunctionDec 3, 2025Break; Break

  METAL RINGS ALL DAMAGED NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707457 ↗
• MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIBIAL INSTRUMENT BROKE DURING KNEE SURGERY. THE SPRING CAME OFF THE ARTICULATING SURFACE AND NEEDS REPLACING. NOTHING WAS LEFT INSIDE THE PATIENT, THE INSTRUMENT DID NOT BREAK IN TWO (THE SPRING CAME OFF), IT DID NOT DELAY THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658768 ↗
• MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENTS WERE MISSING SPRINGS, AND EASILY DISPLACED FROM THE ARCTIC SURFS. BROKEN INSTRUMENTS, HAPPENED DURING SURGERY BUT NO PATIENT AFFECTED, OR SURGERY DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496078 ↗