ATTUNE 2545-00-564Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295133049), received between Jul 11, 2018 and Dec 11, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16, 2026.

Recalls naming this device

1. Jun 12, 2015Terminated

   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-2141-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  ORTHOTECH BROUGHT THIS TO MY ATTENTION IT IS BROKEN, NO FURTHER INFORMATION GIVEN PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778876 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHILE ARTICULATING THE SURFACE SPRING BROKE. THE FEMORAL IMPACTOR HEAD CRACK/BROKE. ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533344 ↗
• 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 23490014 ↗
• 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). (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 23486745 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THE SPRINGS IS MISSING. NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051825 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED THAT ATTUNE INSTRUMENTS ARE BROKEN AND WORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288317 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT THE SHIM HAS WEAR AND TEAR DAMAGE AND ARTIC SURF HAS A CHUNK TAKEN OUT OF THE EDGE OF IT. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER

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

  MAUDE report 21519979 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A SAW WAS ACCIDENTALLY USED TO CLEAN UP BONE AND SHREDDED THE ATTUNE AN ATOMIC BUTTON. THE ARTICULATING SURFACE SNAPPED IN HALF WHEN REMOVING FROM THE KNEE. ALL PIECES WERE REMOVED AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846725 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT THE BROKEN PEG UNDERNEATH TRIAL.

  Patient problems: Insufficient Information

  MAUDE report 20736747 ↗
• MalfunctionJul 2, 2024Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENT IS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655338 ↗
• MalfunctionFeb 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRINGS WOULDN'T RETAIN.

  Patient problems: Insufficient Information

  MAUDE report 18730319 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT THE SPRING HOLDER IS BROKEN. 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. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234233 ↗
• MalfunctionSep 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. DID NOT HAPPEN IN SURGERY. INVESTIGATIONAL FINDINGS DETERMINED THAT THE RETURNED DEVICE WAS MISSING ONE OF THE TWO SPRINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835112 ↗
• MalfunctionJun 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRODUCT WAS DETECTED TO BE INCOMPLETE DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117062 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED THAT THE SHIM IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637190 ↗
• MalfunctionDec 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  ATTUNE ARTICULATION SURFACE SZ4 WAS OPENED FOR R&D PURPOSES, THE ARTICULATION SURFACE WOULD NOT ASSEMBLE TO MATING SHIM AND THEREFORE COULD NOT BE USED. IT WAS OBSERVED THAT 2 BAL SEALS WERE ATTACHED ON THE SMALLER BAL SEAL SIDE OF THE ARTICULATION SURFACE. ONCE THE ADDITIONAL BAL SEAL WAS REMOVED THE SHIM WAS ABLE TO ASSEMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067128 ↗
• MalfunctionJul 19, 2021Break; Break

  1. WHICH PART OF THE INSTRUMENT BROKE? UNKNOWN. AS PER A-5876947 THE INSTRUMENT HAS BEEN RETURNED TO GARETH DIX AND HAS BEEN PACKAGED FOR EXPORT. 2. DID IT BREAK INTO 2 OR MORE PIECES? HOW MANY? UNKNOWN. AS PER A-5876947 THE INSTRUMENT HAS BEEN RETURNED TO GARETH DIX AND HAS BEEN PACKAGED FOR EXPORT. 3. WERE ALL PIECES RETRIEVED FROM THE PATIENT? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194064 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED FOR A BROKEN BAL SPRING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739797 ↗
• MalfunctionMar 11, 2021Break; Break

  ATTUNE IMPACTOR BODY HAS CRACKED. ARTICULATION SURFACE: SMALL BAL SEAL RETAINING POST HAS BROKEN OFF FROM SHIM BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463638 ↗
• MalfunctionJul 16, 2020Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR WAS RETURNED BROKEN. THE ARTICULATE SURFACES HAVE HOLES IN THE PLASTIC, AND THE POST & SPRINGS ON THE ARTICULAR SURFACES HAVE BEEN BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10281210 ↗
• MalfunctionJun 12, 2020Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem

  IT WAS STATED THAT THERE WAS A SURGERY DELAY OF 3 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10148175 ↗
• MalfunctionOct 23, 2019Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL WAS BROKEN WHILE EXTRACTING. ALL PIECES WERE RETRIEVED. NOTHING FURTHER TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225980 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT BROKEN ART SURFACES WERE FOUND DURING INSPECTION OF INSTRUMENTS. POST HAS BEEN BROKEN OFF ON ALL INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677381 ↗