ATTUNE 2545-00-977Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295135548), received between Aug 2, 2017 and May 7, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Break” (40 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-2142-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE INSERT TRIAL SPRING BROKE OFF. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112213 ↗
• MalfunctionDec 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE DEVICE ATTUNE CONV FB PS TB TRL SZ7 WAS RECEIVED FOR ANALYSIS WITH NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE. DURING MANUFACTURER'S PRELIMINARY ANALYSIS OF THE RETURNED DEVICE ON (B)(6) 2025, IT WAS IDENTIFIED THAT THE DEVICE ATTUNE CONV FB PS TB TRL SZ7 IS BROKEN/CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705334 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE WHILE TRAILING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22388076 ↗
• MalfunctionNov 13, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING ON THE BOTTOM OF THE SURFACE BROKE AND WON'T PROPERLY ATTACH. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118016 ↗
• MalfunctionNov 7, 2023Break; Naturally Worn; Break; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED. A. WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICE? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION? -ONE OF THE FEET WERE BENT ON ONE TRIAL, BROKE ON THE SECOND TRIAL, AND THE SPRING WAS STRIPPED ON THE THIRD. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO SURGICAL DELAY. C. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082981 ↗
• MalfunctionJun 27, 2023Crack; Crack

  IT WAS REPORTED THAT THE ARTIC SURFACE PIECE IS CRACKED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210036 ↗
• MalfunctionApr 5, 2023Break; Break

  THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684086 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198538 ↗
• MalfunctionNov 2, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ARTICULATING SURFACE WAS MISSING THE SPRING/SEAL. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713786 ↗
• MalfunctionJun 22, 2022Break; Break

  IT WAS REPORTED THAT THE ARTICULATE SURFACE PEG IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777103 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT SIZE 7 FB ATTUNE INSERT TRIAL BROKE. ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892626 ↗
• MalfunctionSep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ARTICULAR SURFACE WAS FOUND IN THE SPD WITH A MISSING SPRING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416077 ↗
• MalfunctionAug 17, 2021Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE TRIAL IS BROKEN, A PIECE IS ACTUALLY BROKEN OFF. THIS DID NOT DELAY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332866 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT AN ARTICULATING SURFACE PIECE THAT IS BROKEN, A PIECE CHIPPED OFF. THIS WAS HELD OUT IN CENTRAL STERILE, NO PATIENT WAS INVOLVED, NO SURGERY WAS DELAYED, NO ONE WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888746 ↗
• MalfunctionMar 23, 2021Break; Break

  ATTUNE SZ 7 FB ARTICULATING SURFACE BROKE DURING SURGERY. ALL PIECED WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558744 ↗
• MalfunctionJan 13, 2021Crack; Crack

  THE PEG W/O THE SPRING HAS BROKEN OFF. THE PEG WITH THE SPRING HAS THE TOP EDGE CRACKED OFF. BOTH PIECES WERE FOUND AFTER WASHING THE SET DURING INSPECTION. UNSURE OF WHERE BROKEN PIECES ARE. BOTH OF THESE ITEMS MUST HAVE BEEN THIS WAY FOR SOMETIME AS WE HAVE NOT USED THESE SIZES IN A FEW WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166401 ↗
• MalfunctionAug 26, 2020Break; Break

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. IT WAS REPORTED THAT AFTER THE SURGERY, A STAFF FOUND THAT THE REVERSE SIDE SPRING OF THE TIBIAL INSERT TRIAL HAD COME OFF. THE STAFF NOTICED IT AFTER CLEANING THE DEVICES. THERE WAS NO PIECE IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10455237 ↗
• MalfunctionJun 16, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE SIZE 7 FB ART SURFACE TRIAL WAS FOUND TO BE MISSING A SPRING. THE TRIAL WAS NOT USED IN THE CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10158057 ↗
• MalfunctionJun 4, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE DEVICE BROKE NEARLY IN HALF TO LEFT OF THE POST BROKE OFF ENTIRELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118895 ↗
• MalfunctionMay 28, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC PIECE WAS BROKEN OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094951 ↗
• MalfunctionApr 1, 2020Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE 2 PIECES ARTIC SURFACE WERE BROKEN. BOTH HAVE BENT PRONGS AND BROKEN SPRINGS. THESE ARE INTACT AND STILL IN ONE PIECE. THIS DID NOR DELAY SURGERY AND NO ONE WAS INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913739 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL HAD BROKE WHILE TRYING TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9883767 ↗
• MalfunctionSep 10, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE DECONTAM HAS BROUGHT TO OUR ATTENTION WE HAVE SEVERAL SHIMS AND 1 ARTIC SURFACE WITH SHARP EDGES. THEY ARE REQUESTING THESE ITEMS BE REPLACED. THERE WAS NOT A PATIENT IN THE ROOM WHEN ITEMS WERE DISCOVERED DAMAGED. NOBODY WAS INJURED BY DAMAGED ITEMS. THIS DID NOT DELAY A SURGERY. ALL PIECES ARE INTACT, AND ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8983591 ↗
• MalfunctionAug 15, 2019Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE ARTIC SURFACE PIECE HAS BROKEN PRONG, AND SPRING AROUND PRONG WAS MISSING. NO SURGICAL DELAY AND NO ONE WAS INJURED. ITEM WAS NOT USED DURING PROCEDURE. ITEM NEEDS TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898833 ↗
• MalfunctionJul 19, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN IN OFFICE SETS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807676 ↗