ATTUNE 2545-00-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10603295132486), received between Jun 26, 2017 and Aug 26, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Break” (48 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-2137-2015 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453839 ↗
• MalfunctionMar 31, 2026Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROPLASTY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SPRING CAME OFF THE BACK OF A TRIAL DUE TO DAMAGE OF THE TRIAL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742011 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT TRIALS WERE CRACKED OR BROKEN AND THE HOSPITAL WILL NOT ACCEPT THEM. THE ANGEL WING WAS BENT, AND THE TIBIA IMPACTOR HAS POPPED ITS SPRING. THE POLY LOST A SPRING ON ONE OF THE POSTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729798 ↗
• MalfunctionDec 9, 2025Material Integrity Problem; Material Integrity Problem

  ¿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.¿ SMALL ROUND FOOT OF TRIAL IS DAMAGED 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, (B)(4). 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 23759406 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT THE ATTUNE SIZE 8 PS FB TRIAL WAS BROKEN. THE MEDIAL POSTERIOR ARTICULATING SURFACE SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500636 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THE SPRING ON THE ONE SIDE OF THE ARTICULATING SURFACE BROKE WHEN TRAIL WAS TAKEN OUT BY SURGEON. SURGEON CONTINUED AS THERE WAS ANOTHER DEVICE ON THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076607 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885113 ↗
• MalfunctionAug 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SPRING OF THE ARTICULATE SURFACE IS LOOSE ON THE DEVICE. THE ISSUE HAPPENED DURING A PROCEDURE. NO ADVERSE OUTCOME WAS REPORTED, AND THE SURGERY WAS NOT PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771334 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT THE PART CAME OFF THE DEVICES 254401004 AND 255000100 AND THE DEVICE 254500508 WAS CHIPPED. ADDITIONALLY, THERE WAS AN UNKNOWN MALFUNCTION/ALLEGATION AGAINST THE DEVICES 620120121 AND 254401017. IT DIDNT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358808 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIBIA INSERTS FROM ATTUNEM5 WERE REPORTED HAVE SPRING LOOSENED BEFORE OPERATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938219 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE POST BROKE OFF OF TRIAL DURING TRIALING. THERE WERE NO DELAYS OR HARM TO PATIENT. ALL PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908098 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT THE FEMORAL TRIAL WAS DROPPED ON THE FLOOR, AND THE TWO ARTICULATING SURFACES SPRINGS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21343472 ↗
• MalfunctionNov 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FOUND IN A TRAY WITH THE SPRING BENT. THERE WAS NO SURGICAL DELAY AND NO SURGICAL CONSEQUENCES. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT ONE OF THE SPRINGS FROM THE ATTUNE FB PS ARTIC SURF SZ8 IS DEFORMED, ALSO THE POST IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675479 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT PART OF THE KNOB HAS CHIPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 20223165 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTS A SPRING IS MISSING FROM THE UNDERSIDE OF AN ARTICULATING SURFACE OF THE TIBIAL INSERT TRIAL. ISSUE WAS IDENTIFIED PRIOR TO START OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629665 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101245 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED. IT WAS NOTICED, AT THE START OF SURGERY. THAT THE SPRING WAS MISSING, SO IT WAS NOT USED FOR THE PROCEDURE. AND AN ALTERNATIVE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711844 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT THE SHIM WAS BROKEN BEFORE THE CASE WAS STARTED. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512112 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT ARTICULATING SURFACE HAD A CHIP MISSING. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108109 ↗
• MalfunctionMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SMALL SPRING ON BACK OF SURFACE FOUND MISSING WHEN INSTRUMENT INSPECTED PRIOR TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947491 ↗
• MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE THREADED INSERTER WAS LOOSE AND THERE WAS A JINGLE SOUND WHEN SHAKING. THE ARTICULATION SURFACE WAS MISSING A SPRING ON THE BOTTOM. THE SPRING WAS MISSING THE PLASTIC WAS STILL FULLY INTACT. DISCOVERY MADE IN STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773811 ↗
• MalfunctionNov 30, 2022Break; Break

  IT WAS REPORTED THAT THE DISTAL FEMORAL CUTTING BLOCK- WHEN DRILLING FOR FIXATION PINS, THE BLOCK WOULD CATCH THE DRILL BIT AND NOT ALLOW IT TO ADVANCE. FEMORAL IMPACTOR- DURING IMPLANT IMPACTION A SMALL PIECE FROM THE FEMORAL IMPACTOR BROKE OFF AND THE IMPACTOR ALSO HAS A CRACK IN IT. ARTICULAR SURFACE- DURING REMOVAL OF TRIALS THE ARTICULAR SURFACE WAS REMOVED AND THE POST WITH THE SPRING SNAPPED OFF. THERE WAS A 10MIN OF SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886117 ↗
• MalfunctionOct 31, 2022Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENT WAS INSERTED SMALL CRACK FORMED ON BOTH TRIAL POLYS, ALL PARTS WERE RECOVERED. SURGICAL TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15702443 ↗
• MalfunctionOct 31, 2022Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENT WAS INSERTED SMALL CRACK FORMED ON BOTH TRIAL POLYS, ALL PARTS WERE RECOVERED. SURGICAL TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15702435 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT THE PEG ON BOTTOM OF TRIAL BROKE OFF. 2 PIECES BROKE OFF. THE SPRING AND THE PEG. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446982 ↗