ATTUNE 2545-00-548Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM POSTERIOR STABLIZED SIZE 8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune knee trial component has 205 adverse event reports: no deaths and 1 injury. Most reports describe parts such as pegs, springs or shims breaking off, and a few describe surgeons searching for fragments. One recall, started in June 2015 over a small spring that could separate and enter the surgical site, is closed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 206
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 10603295132882), received between Jul 12, 2017 and Sep 10, 2026 — classified as 1 injury, 205 malfunctions.
The most frequently reported specific device problem is “Break” (159 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.
Reports received per month
Recalls naming this device
- 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-2139-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break159
- Detachment of Device or Device Component27
- Component Missing10
- Material Deformation8
- Crack6
- Device-Device Incompatibility4
- No Apparent Adverse Event4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions104
- No Consequences Or Impact To Patient70
- No Information16
- Insufficient Information12
- No Code Available2
- Not Applicable2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724056 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT MISSING ONE OF THE SHIM POST ATTACHMENTS. NOTICED DURING SET UP. NOT USED ON PATIENT. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755541 ↗MalfunctionMar 20, 2026Break
ADDITIONAL INFORMATION RECEIVED: THE LITTLE PIECE WITH THE SPRING ATTACHED BROKE OFF, DID NOT SEE ANY FRAGMENTS & NO IT DID NOT BREAK INTO ANYMORE PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651252 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THE BOTTOM PEGS ON ARTICULATING SURFACES BROKE OFF WHEN SCRUB TECH TIRED TO REMOVE SHIMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500117 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THE BOTTOM PEGS ON ARTICULATING SURFACES BROKE OFF WHEN SCRUB TECH TIRED TO REMOVE SHIMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500011 ↗MalfunctionJan 12, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE THE SIZE 8/7 6 MM SHIM BROKE IN HALF AND SIZE 8 RP ARTIC SURF ALSO BROKE. MOST PIECES INCLUDING SPRINGS WERE RECOVERED AND THE SURGEON WAS CONFIDENT THAT NOTHING WAS LEFT IN THE JOINT AFTER SPENDING APPROXIMATELY FIVE MINUTES RETRIEVING FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24036576 ↗MalfunctionDec 17, 2025Break; Break
IT WAS DISCOVERED BY CENTRAL SUPPLY DURING THE CLEANING PROCESS THAT ATTUNE ARTICULATING SURFACE TRIAL WAS BROKEN. IF OTHER, DESCRIBE NOT ASSOCIATED WITH ANY SURGERY, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IF YES, DESCRIBE NO PATIENT INVOLVEMENT, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827590 ↗MalfunctionDec 13, 2025Break; Break
IT WAS REPORTED THAT DURING A RIGHT TOTAL KNEE REPLACEMENT SURGICAL PROCEDURE, THE ROTATING PLATFORM (RP) ARTICULATING SURFACE PEG BROKE OFF ALONG WITH THE SPRING. IT WAS REPORTED THAT THE BROKEN PIECE WAS SEARCHED FOR AND X-RAYS WERE TAKEN TO MAKE SURE IT WAS NOT IN THE WOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23797736 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT BROKEN POLY TRIAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511016 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438868 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT THE RPR TOP BUMP BROKE INSIDE OF THE SHIM. THERE WAS NO PATIENT HARM. NO SURGICAL DELAY. ALL PIECES WERE REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23305999 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797187 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THAT PRIOR TO A CASE, INSTRUMENTS FOUND DEFECTIVE IN SETS. SHIM - CRACK IN THE INSTRUMENT. ART SURFACE - PEG SHEARED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679561 ↗MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT THE ART SURFACE POST WAS BROKEN OFF OF THE SZ8 RP INSERT TRIAL. THIS WAS NOTICED DURING CASE SETUP. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL PIECES WERE ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359589 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT ATTUNE PS FEM TRIAL SZ 7 LT WAS SCRATCHED, QUICKSET ACE GRATER HEAD 49MM WAS BROKEN, QUICKSET ACE GRATER HEAD 47MM WAS BROKEN, ATTUNE RP PS ARTIC SURF SZ8 WAS BROKEN, AND ATTUNE FEMORAL IMPACTOR WAS ALSO BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22348301 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THE SPRING AND PLASTIC PIECE BROKE OFF THE ATTUNE ARTICULATING SURFACE. SURGICAL DELAY UNKNOWN. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22196138 ↗MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY, SPRING ON ARTICULATING SURFACE WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157618 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Scratched Material; Detachment of Device or Device Component; Scratched Material
IT WAS REPORTED THAT THE ARTICULATION SURFACE IS MISSING THE SPRING FROM IT. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004252 ↗MalfunctionMay 1, 2025Break; Break
IT WAS REPORTED THAT THE THE SIZE 8 PS ARTICULAR SURFACE BROKE DURING TRIALING DURING A ROUTINE KNEE REPLACEMENT. IT WAS A CLEAN BREAK AND BOTH PIECES WERE RETRIEVED. A NEW ARTICULAR SURFACE WAS USED AND THE CASE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942683 ↗MalfunctionApr 29, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE DAMAGED DURING ROUTINE INSPECTIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928137 ↗MalfunctionApr 21, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, AND THE SPRINGS ON THE ITEM BROKE OFF AND WOULDN'T CONNECT WITH SHIMS. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874777 ↗MalfunctionApr 21, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, AND THE SPRINGS ON THE ITEM BROKE OFF AND WOULDN'T CONNECT WITH SHIMS. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874773 ↗MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING CAME OFF THE PEG ON ARTICULATING SURFACE TRIAL.
Patient problems: Insufficient Information
MAUDE report 21766979 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21633872 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21633779 ↗
Other TEMPLATE devices
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- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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