ATTUNE 2545-00-547Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM POSTERIOR STABLIZED SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune knee trial component has 231 adverse event reports, 230 of them malfunctions, and 1 injury, with no deaths. The reports mostly describe trial parts such as articulating surfaces, shims and pegs breaking during use, usually with no patient involvement. 1 recall names this device. It began in June 2015 and is closed; it concerns a small spring coil on the trial posts that could come loose and enter the surgical site.
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
- 231
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 10603295132875), received between Jun 22, 2017 and Sep 8, 2026 — classified as 1 injury, 230 malfunctions.
The most frequently reported specific device problem is “Break” (181 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.
Reports received per month
Recalls naming this device
- 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-2139-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break181
- Detachment of Device or Device Component17
- Material Deformation10
- Component Missing9
- Crack8
- Device-Device Incompatibility6
- Material Integrity Problem6
- Appropriate Device Problem Term/Code Not Available4
Patient problems
- No Clinical Signs, Symptoms or Conditions124
- No Consequences Or Impact To Patient86
- No Information10
- Insufficient Information9
- No Code Available6
- Not Applicable2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 231 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677923 ↗MalfunctionJul 28, 2026Appropriate Device Problem Term/Code Not Available
It was reported that during this case, while trailing, both size 7 PS RP trials, the size 5/6 5mm and the size 7/8 5mm shims all broke. There was no harm to patient or delay and all pieces of the broken trial were found.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063158 ↗MalfunctionJun 17, 2026Break
IT WAS REPORTED THAT THE SIZE 7 RP ARTICULATING SURFACE WAS BROKEN WHILE TRIALING AN INSERT. A REPLACEMENT WAS USED. THERE WAS NO DELAY IN SURGERY OR OUTCOME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534742 ↗MalfunctionJun 1, 2026Crack
FOUND DURING ROUTINE INSPECTION. PLASTIC TRIAL CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355283 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT AN UNDERSIDE PEG ON A SZ 7 PS POLYETHYLENE TRIAL BROKE OFF WHILE REMOVING A SHIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24819308 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT PEG BROKE ON PS SZ 7 TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754196 ↗MalfunctionApr 1, 2026Break
IT WAS OBSERVED AT CENTRAL SUPPLY THAT THE ARTICULATING SURFACE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753625 ↗MalfunctionMar 31, 2026Break
IT WAS OBSERVED BY CENTRAL SUPPLY THAT THE ARTICULATING SURFACE AT TUNE TRIAL WAS BROKEN.NO PATIENT INVOLVEMENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741075 ↗MalfunctionMar 20, 2026Break
IT WAS REPORTED THAT THIS PIECE CAME OUT OF SPD BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651135 ↗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 24500204 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT THE ATTUNE ARTIC SURF SZ7 RP HAD A PEG BROKEN FROM THE UNDERSIDE SURFACE. IT WAS REPORTED THAT THE PIECE DISLODGED, WAS LOCATED, AND REMOVED FROM THE FIELD. SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434642 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT ONE OF THE SPRINGS WAS BROKEN. REPLACEMENT IS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367387 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIALS WERE BROKEN WHEN THE SCRUB TECH WAS TAKING THEM APART FOR CLEANING. IT WAS REPORTED THAT ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO DELAY IN THE PROCEDURE, AND NO IMPACT TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24229568 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT THE BOTTOM TAB ON THE ARTICULATING SURFACE WAS BROKEN OFF UPON REMOVAL DURING THE TRIAL STAGE OF THE TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202664 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT BUTTON BROKE OFF OF ARTICULATING CONSTRUCT WHEN IT WAS REMOVED AFTER TRAILING INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24191828 ↗MalfunctionJan 23, 2026Break
IT WAS REPORTED THAT SPRING BROKEN. NEEDS REPLACEMENT. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162072 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THAT THE PS TRIAL SNAPPED. IT WAS REPORTED THAT THERE WERE NO ADVERSE OUTCOMES OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136717 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT SPRINGS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096379 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT THE KNOB ON POLY TRIAL BROKEN OFF INTO THE SHIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093899 ↗MalfunctionJan 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT CENTRAL SUPPLY DISCOVERED ONE ATTACHMENT FOOT WAS MISSING. THE EVENT WAS NOT ASSOCIATED WITH ANY SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052527 ↗MalfunctionDec 23, 2025Break; Break
IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE SCREWDRIVER HANDLE HAD SOMETHING STUCK IN THE CANNULATED HOLE AND RP PS ARTIC SURFACE HAD A BROKEN PEG. NOTHING FURTHER TO REPORT. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882294 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE TIBIAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438852 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE TIBIAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438849 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE TIBIAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438848 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435864 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- 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 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-526Depuy (Ireland) · TEMPLATE1 recall218 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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