ATTUNE 2544-01-005Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL INTRODUCER · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune femoral introducer is a surgical instrument used during knee replacement. Most of the 1,368 reports describe parts of the instrument breaking, such as a handle, knob or clip breaking off, sometimes while implanting. The reports include no deaths, 1 injury and 1,367 malfunctions. No recalls name this device.
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
- 1,383
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,383 adverse event reports that list this exact device (DI 10603295130215), received between Jun 21, 2017 and Sep 23, 2026 — classified as 1 injury, 1,382 malfunctions.
The most frequently reported specific device problem is “Break” (1,297 reports).
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
Most reported problems
Device problems
- Break1,297
- Crack32
- No Apparent Adverse Event23
- Device-Device Incompatibility21
- Fracture10
- Naturally Worn10
- Mechanical Jam9
- Detachment of Device or Device Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions904
- No Consequences Or Impact To Patient319
- Insufficient Information141
- No Information24
- No Code Available21
- Not Applicable5
Recent adverse event reports
The 25 most recent of 1,383 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026No Apparent Adverse Event
It was reported that during a total knee arthroplasty surgery, the device had an unspecified malfunction. During evaluation, it was determined that the wing knob screw component on the ATTUNE FEMORAL INTRODUCER device was broken.
Patient problems: Insufficient Information
MAUDE report 50871915 ↗MalfunctionSep 23, 2026Break
It was reported that femoral initiator broken, red outer knob broken off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869017 ↗MalfunctionSep 22, 2026Break
It was reported that the femoral Initiator red handle knob was fallen off. It was reported that all fragments were retrieved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852314 ↗MalfunctionSep 21, 2026Break
It was reported that adjusting knob broke off during surgery. All pieces recovered. No surgical delay. Instrument removed from tray.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841532 ↗MalfunctionSep 21, 2026Break
It was reported that the lateral knob to tighten/loosen has broken off. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840877 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822704 ↗MalfunctionSep 17, 2026Break
It was reported that both femoral holders broke on impacting the femoral prosthesis, no damage to the patient or implant was reported. Another Instrument was used from another set.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804682 ↗MalfunctionSep 17, 2026Break
It was reported that both femoral holders broke on impacting the femoral prosthesis, no damage to the patient or implant was reported. Another Instrument was used from another set.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804673 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794858 ↗MalfunctionSep 14, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764554 ↗MalfunctionSep 14, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764511 ↗MalfunctionSep 14, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764504 ↗MalfunctionSep 14, 2026Leak/Splash
It was reported that the VELYS SAW HANDPIECE device was leaking an oily substance where the blade inserts. It was not reported if the device was used in surgery. There was no delay to the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755089 ↗MalfunctionSep 11, 2026Break
It was reported that the attune femoral introducer broke on impacting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737312 ↗MalfunctionSep 11, 2026Break
It was reported that femoral introducer side tightening handle broke off at the threads. Device broke into two pieces during cleaning. The event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734367 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698578 ↗MalfunctionSep 9, 2026Device-Device Incompatibility
It was reported that during an unspecified surgical procedure it was observed that the femoral introducer on attune primary tray allows too much movement of the implant on the handle when the implant is being inserted. The surgeon stated that this makes it difficult to insert the femoral implant accurately. There was no patient harm, or surgical delay. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692571 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677057 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677055 ↗MalfunctionSep 3, 2026Break
It was reported that the femoral introducer was broken during case. The red tightening knob fell off. All pieces were removed. No more information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587395 ↗MalfunctionAug 31, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531506 ↗MalfunctionAug 28, 2026Break
It was reported that the femoral introducer handle was broke. Both pieces were recovered. No additional surgery time was required. Backup instruments were on hand.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496764 ↗MalfunctionAug 27, 2026Break
It was reported that the red piece on the femoral introducer broke off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483649 ↗MalfunctionAug 27, 2026Break
It was reported that during a Total Knee Arthroplasty (TKA) surgery the tightening knob on the femoral introducer broke off. The incident occurred after the implants had been secured in place. The surgery was successfully completed. There were no delays to the procedure. There were no adverse events.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476689 ↗MalfunctionAug 27, 2026Break
It was reported that the Impactor handle broke while implanting the femur. It did not impact the case
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476600 ↗
Other DRIVER, PROSTHESIS devices
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
- INHANCE 6205-10-105Depuy (Ireland) · DRIVER, PROSTHESIS191 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
- 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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