ATTUNE 2545-00-525Recalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 10603295132653), received between Jun 29, 2017 and Jun 30, 2026 — classified as 161 malfunctions.

The most frequently reported specific device problem is “Break” (124 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 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT ONE OF THE PEGS ON THE UNDERSIDE OF THE SZ 5 POLY ARTICULATING SURFACE SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665332 ↗
• 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 25414059 ↗
• 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 25071740 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT ONE OF THE TRIAL INSERTS HAD BEEN BROKEN, BUT NO DELAY ON THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627707 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAS A BROKEN SNAP ON THE PEG LOCATED ON THE BOTTOM SIDE OF THE ARTICULATING SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524367 ↗
• MalfunctionMar 3, 2026Break; Material Deformation

  IT WAS REPORTED THE SPRINGS WITHIN THE ARTICULAR SURFACE TRIALS WERE DESCRIBED AS BECOMING TWISTED AND SNAPPING DURING USE, WITH SPECIFIC REFERENCES TO SPRINGS BEING DAMAGED AND UNRAVELLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497823 ↗
• MalfunctionMar 3, 2026Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED: A. WHAT DO YOU MEAN BY DAMAGED? WAS IT BROKEN INTO TWO OR MORE PIECES, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? SPRING BECAME TWISTED WHICH WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497793 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE SPRING HAS BENT AND COME OFF OF THE ARTICULATING SURFACE. THERE WERE NO DELAYS TO SURGERY, NOTHING WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400047 ↗
• MalfunctionFeb 12, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS REPORTED WITH AN UNSPECIFIED ALLEGATION. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ATTUNE FB CR ARTIC SURF SZ5 HAS ONE OF THE POSTS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323865 ↗
• MalfunctionFeb 2, 2026Break; Material Deformation

  IT WAS REPORTED THAT MULTIPLE SPRINGS ON ARTICULAR SURFACE TRIALS AND SPACER BLOCK INSTRUMENTS BECAME TWISTED AND DAMAGED INTRAOPERATIVELY AND AT TIMES WERE SNAPPING. RETAINMENT CONCERN. INSTRUMENT REQUIRES REPLACEMENT WHICH RESULTS IN TRAY BEING DELAYED FOR USE. EQUIPMENT: DEPUY SYNTHES ATTUNE KNEE INSTRUMENTS. ARTICULAR SURFACE TRIALS (CR & PS) AND SPACER BLOCK INST. SPRINGS WITHIN INSTRUMENTS BECOMING TWISTED AND SNAPPING WHEN IN USE. TYPE OF DEVICE: IMPLANTATION INSTRUMENTS AND ACCESSORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229627 ↗
• MalfunctionFeb 2, 2026Break; Material Deformation

  IT WAS REPORTED THAT MULTIPLE SPRINGS ON ARTICULAR SURFACE TRIALS AND SPACER BLOCK INSTRUMENTS BECAME TWISTED AND DAMAGED INTRAOPERATIVELY AND AT TIMES WERE SNAPPING. RETAINMENT CONCERN. INSTRUMENT REQUIRES REPLACEMENT WHICH RESULTS IN TRAY BEING DELAYED FOR USE. EQUIPMENT: DEPUY SYNTHES ATTUNE KNEE INSTRUMENTS. ARTICULAR SURFACE TRIALS (CR & PS) AND SPACER BLOCK INST. SPRINGS WITHIN INSTRUMENTS BECOMING TWISTED AND SNAPPING WHEN IN USE. TYPE OF DEVICE: IMPLANTATION INSTRUMENTS AND ACCESSORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229619 ↗
• MalfunctionJan 15, 2026Break; Material Deformation

  IT WAS REPORTED THAT THE SPRING OF THE DEVICE WAS FOUND DAMAGED/FRAYED BY SSD ( STERILE SERVICES DEPARTMENT ). THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO CONSEQUENCE TO THE PATIENT DUE TO THE EVENT. THERE WERE NO SURGICAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080780 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PART OF A FITTING INSERT BROKE OFF DURING A FITTING WITH A 10MM SHIM (ON A 5 FB FITTING INSERT). IT WAS REPORTED THAT THE SURGEON DID NOT HIT IT WITH A HAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075906 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE SHIMS AND ARTICULATING SURFACE WERE BROKEN AND NEEDED TO BE REPLACED. BROKEN INSTRUMENTS WERE NOT USED IN SURGERY AND THERE WAS NO DELAY CAUSED THEREFROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888873 ↗
• MalfunctionDec 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO DID THE EVENT HAPPEN DURING A PROCEDURE? YES WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES EVENT OUTCOME/HOW WAS IT MANAGED? THERE WAS A SECOND ONE ON THE SET WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO WAS THE SURGERY PROLONGED DUE TO THE EVENT? NO HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO PLEASE GIVE A DETAILED EXPLANATION OF EVENT: THE 2 SPRINGS ON THE UNDERSIDE OF THE ARTICULATING SURFACE WERE NOTICED TO BE MISSING. THE ARTICULATING SURFACE CANNOT STAY CLIPPED ONTO THE SHIM AS IT IS DESIGNED TO WITHOUT THE SPRINGS IN SITU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861263 ↗
• 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 23846240 ↗
• MalfunctionDec 8, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE SPRING WAS MISSING FROM THE BOTH ARTICULATION SURFACE. AS PER THE IMAGES ATTACHED. THE PRODUCT DAMAGE WAS 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 23744718 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT THE SPRING ON THE ATTUNE DEVICE WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719620 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTUNE ARTICULATING SURFACE WAS BROKEN AND WORN. IT WAS REPORTED THAT THE SPRING AND THE PLASTIC HAD SNAPPED OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533047 ↗
• 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 23495905 ↗
• 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 23489960 ↗
• 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 23486096 ↗
• 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 23404212 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN SPRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378589 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT THE BACK OF THE SIZE 5 POLY TRIAL THAT THE SHIMS CONNECT 2 BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717642 ↗