ATTUNE 2545-00-527Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 10603295132677), received between Sep 8, 2017 and Sep 2, 2026 — classified as 140 malfunctions.

The most frequently reported specific device problem is “Break” (111 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566559 ↗
• 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 25414261 ↗
• MalfunctionMay 22, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SPRING ON THE ARTICULATING SURFACE HAD COME LOOSE AND WAS MISSING FROM ARTICULATING SURFACE. THERE WERE NO REPORTS OF SPRING COIL BEING LEFT IN PATIENT. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THE EVENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256246 ↗
• MalfunctionMay 8, 2026Break

  SPRINGS ARE BROKEN ON THE ARTICULATING SURFACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126668 ↗
• MalfunctionMay 8, 2026Break

  SPRINGS ARE BROKEN ON THE ARTICULATING SURFACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125508 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE SURGEON NOTICED CR TRIAL INSTRUMENT WAS BROKEN DURING THE OPERATION. THERE WAS NO SURGICAL DELAY. THE DAMAGED CR TRIAL WAS REMOVED AND ALTERNATE TRIAL WAS USED. THE PROCEDURE WAS COMPLETED. SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110319 ↗
• 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 25071943 ↗
• MalfunctionApr 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT POST-SURGERY ONE SPRING WAS MISSING FROM THE ATTUNE ARTICULATING SIZE 7 TRIAL. THE EVENT DID NOT OCCUR DURING A PROCEDURE. THE THEATRE MANAGER AND STERILE SERVICE LEAD WERE SPOKEN WITH TO MANAGE THE ISSUE. THERE WAS NO CONSEQUENCE TO THE PATIENT, AND THE SURGERY WAS NOT PROLONGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839647 ↗
• MalfunctionApr 9, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT ONE OF THE SPRING ON THE SURFACE IS LOOSE AND HAS BEEN DAMAGED. IT WAS REPORTED THAT THE SPRING BECOME LOOSE AND HAS BROKEN FROM THE ITEM. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830525 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT THE SPRING ON INSERT TRIAL WAS BROKEN AND NOT ALLOWING THE SHIM TO SNAP ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603625 ↗
• MalfunctionDec 29, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE PAINT ON THE MARKINGS IS PEELING. IT APPEARS TO BE PAINT, NOT STICKERS.NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905612 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT AN INSTRUMENT BROKE DURING SURGERY. NO IMPACT TO PATIENT CARE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854218 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BITS WERE BROKEN. IT WAS FURTHER REPORTED THAT THE SPRING WENT OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846314 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE KNEE IT WAS OBSERVED THAT A PIN OF THE ATTUNE DEVICE BROKE OFF DURING DISASSEMBLY. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY AS ALL FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733500 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE SPRINGS BROKE OFF THE INSTRUMENT. IT WAS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597543 ↗
• 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 23496131 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SPRINGS SPANNED OFF OF THE ATTUNE ARTICULATION SURFACE FIXED BEARING CRUCIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489988 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SPRINGS FELL OFF IN COUPLE OF PROCEDURES. (B)(4) IS RELATED TO (B)(4). (B)(4) IS THE MOTHER COMPLAINT. (B)(4) WERE CREATED TO CAPTURE THE ADDITIONAL IPS OF THE MOTHER COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486379 ↗
• MalfunctionNov 5, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING KNEE SURGERY THE SPRING WAS MISHAPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479914 ↗
• MalfunctionNov 5, 2025Break; Break

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED THAT BROKEN SPRINGS FROM THE ATTUNE FB CR ARTIC SURF SZ7 WERE DISCOVERED UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475922 ↗
• MalfunctionNov 5, 2025Break; Break

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED THAT BROKEN SPRINGS FROM THE ATTUNE FB CR ARTIC SURF SZ7 WERE DISCOVERED UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475914 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT TWO SPRINGS/ RINGS ON THE BACK OF THE ARTICULATE SURFACE FBCR ON THE ATTUNE TRAY ESSENTIAL FEMORAL PREP CR SIZE 7 WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390666 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS ATTEMPTING USE TRIAL AND WHEN DISASSEMBLING ITEM, NOTICED MISSING PIECE. AN ALTERNATIVE SET WAS OPENED THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22859334 ↗
• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING WAS MISSING AFTER WASHING. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848568 ↗
• MalfunctionJul 30, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED DURING THE PROCEDURE, THE METAL SPRINGS FROM THE UNDERSIDE OF THE ARTICULATING SURFACE HAVE BECOME DETACHED/FALLEN OFF. THE SPRINGS ARE MISSHAPEN AND STRETCHED AND SO CANNOT BE REATTACHED SECURELY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664527 ↗