ATTUNE 2545-00-528Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295132684), received between Jun 30, 2017 and Sep 25, 2026 — classified as 82 malfunctions.

The most frequently reported specific device problem is “Break” (56 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, the device springs broke.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898147 ↗
• MalfunctionAug 26, 2026Break

  It was reported that Attune trials were broken and that pulled from pans buildup had generated multiple codes. Dates for each code breaking were not available. Notification was made in the morning. There were no adverse consequences that affected the patient due to the reported event. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453825 ↗
• MalfunctionAug 21, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50371864 ↗
• MalfunctionJun 8, 2026Break

  BROKEN SPRING ON TRIAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO PATIENT INVOLVEMENT. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? 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 25427326 ↗
• 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 25414072 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING FROM THE BACK OF THE SURFACE WAS IDENTIFIED AS MISSING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788901 ↗
• MalfunctionJan 23, 2026Material Integrity Problem

  IT WAS REPORTED THERE WAS AN ISSUE WITH A TRIAL IN A CONSIGNMENT SET. NO SURGICAL DELAY DEVICE RECEIPT AND INVESTIGATION DETERMINED THE DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160823 ↗
• 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 23658781 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568780 ↗
• 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 23496105 ↗
• 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 23489969 ↗
• 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 23486150 ↗
• MalfunctionOct 28, 2025Crack; Crack

  IT WAS REPORTED TWO OF THE ITEMS SHOWS RADIAL CRACKS AND ONE (SIZE 6), SHOWS A BROKEN PEG AT THE ATTACHMENT SITE FOR THE ARTICULAR SHIMS. THE BROKEN PIECE IS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404688 ↗
• MalfunctionOct 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SSD NOTED THAT THE THE SPRING WAS MISSING ON THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392391 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT THE ITEMS WERE BROKEN ON AN UNKNOWN DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939147 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTUNE SHIMS WERE NOTED TO HAVE DAMAGE/WORN SPRINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885148 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED EQUIPMENT BREAKAGE OF MULTIPLE ITEMS OF A SET FROM GENERAL USAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529314 ↗
• MalfunctionJul 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WERE MULTIPLE CR ARTIC SURFACES WHERE THE SPRINGS HAVE BROKEN OFF AND ARE NOW MISSING. THIS OCCURRED DURING THE TIME OF THE PROCEDURE. THEY WERE REMOVED FROM THE SET. THERE WERE NO PATIENT CONSEQUENCE. PRODUCT NAME: ATTUNE FB CR ARTIC SURF PRODUCT CODE: 254500523/ 254500526/ 254500527/ 254500528, SIZE 3(254500523) X2, SIZE 6(254500526) X2, SIZE 7 (254500527X1, SIZE 8 (254500528) X1, SET CODE: LKATTC003CN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385170 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT AN ATTUNE ARTICULATING SURFACE WAS DAMAGED. THE TRIAL PLASTIC WAS BROKEN WHERE THE SPRING IS HELD AND THE SPRING IS DAMAGED. NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205114 ↗
• MalfunctionJun 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A BROKEN INSTRUMENT. THE SPRING HAS BECOME LOOSE. THERE WAS NO PATIENT EFFECT OR DELAY REPORTED. FOUND DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123853 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE ARTICULATING SURFACE SPRING WAS BROKEN IN A SET. THIS WAS NOTED DURING INSPECTION OF THE SET DURING STERILE PROCESSING ON AN UNKNOWN DATE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873065 ↗
• MalfunctionMar 12, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT WHEN PUTTING TOGETHER ITEMS IN SHIMS TRAY IT WAS NOTICED THAT ONE SPRING WAS BENT AND ANOTHER WAS MISSING SPRINT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588538 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. A METAL SPRING CAME OFF OF THE TRIAL. THE SPRING WAS LOCATED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561517 ↗
• MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTUNE TRIAL WAS MISSING A COIL SPRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529226 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT THE SMALL WIRE SPRING BROKE. IT WAS REMOVED FROM THE SET. THERE WAS NO PATIENT OR PROCEDURE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178254 ↗