ATTUNE 2545-01-969Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295423416), received between Jan 29, 2020 and Apr 13, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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-2146-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Detachment of Device or Device Component

  EVENT DESCRIPTION: WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? IN THEATRE ¿ REPORTED VIA STERILE SERVICES POST CASE EVENT OUTCOME/HOW WAS IT MANAGED? SPOKEN WITH THEATRE MANAGER & STERILE SERVICE LEAD 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 THE EVENT: INFORMED TODAY POST CASE THAT ONE SPRING WAS MISSING OFF THE ATTUNE ARTICULATING SIZE 9 TRIAL, THIS WAS REPORTED BY THE STERILE SERVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865572 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO ATTACH TO THE POLY TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23456255 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE AT SPRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305773 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS NEED REPLACEMENT. THIS DID NOT HAPPEN IN SURGERY. THERE WAS NO SURGICAL DELAY. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895159 ↗
• MalfunctionMar 25, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: Insufficient Information

  MAUDE report 18967668 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN BALL SPRINGS. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402463 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT BROKEN BAL SPRINGS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127666 ↗
• MalfunctionOct 17, 2023Break; Scratched Material; Break; Scratched Material

  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. PHOTO ANALYSIS OF THE ATTUNE FB CR ART SURF SZ9 CONV FOUND SURFACE SCRATCHES AND PORTION OF TOP EDGE WAS CHIPPED OFF. AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. 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, IP- (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 17950868 ↗
• MalfunctionAug 4, 2023Break; Break

  IT WAS REPORTED THAT THE ATTUNE SHIM WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463314 ↗
• MalfunctionMay 13, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE PART BROKE WAS THE LEFT SIDE LOOKING ANTERIOR & DOWN AND 1/4 OF THE TOTAL M/L WIDTH BROKE OFF WITH A DEFINITIVE PORTION OF THE LEFT ARTICULAR SURFACE. THE ENTIRE ARTICULAR TRIAL WAS RETRIEVED AND BROKE INTO 2 PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820152 ↗
• MalfunctionSep 23, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING ON SIZE 9 FB ARTICULATING SURFACE CAME OFF DURING USED. ALL PIECES RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10577105 ↗
• MalfunctionSep 16, 2020Break; Break

  HAS PRODUCT BEEN POTENTIALLY CONTAMINATED OR IS CONTAMINATED WITH BODILY FLUIDS? YES. 2545-00-928 HAS A CRACK THAT WAS DISCOVERED DURING CLEANING/STEAM STERILIZATION. 2545-01-969 HAS BROKEN INTO 2 PIECES THAT HAPPENED PER-OP. 2544-00-502 A PIECE OF PLASTIC FELL OFF DURING USE PER-OPERATIVE. WHERE / WHEN DID THE EVENT OCCUR? INTRA-OP, POST - OP WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT.

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

  MAUDE report 10541469 ↗
• MalfunctionJan 29, 2020Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  CORRECTED CODES FOR IP-(B)(4) (ATTUNE FB CR ART SURF SZ9 CONV) FROM BROKEN (2+ PIECES) TO DEFORMED/BENT AND ADDED DEVICE INTERACTION (2+ DEVICES)/ UNABLE TO ASSEMBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643742 ↗