ATTUNERecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 19 models of ATTUNE by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and May 1, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Break” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ATTUNE problems
Device problems
- Break14
- Device-Device Incompatibility9
- Mechanical Jam4
- Structural Problem3
- Scratched Material2
- Contamination /Decontamination Problem1
- Crack1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient4
- Insufficient Information3
ATTUNE models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ATTUNE 2999-65-994TEMPLATE12 reports
- ATTUNE 2999-66-301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ATTUNE 2999-65-599PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ATTUNE 2999-65-860TEMPLATE1 report
- ATTUNE 2999-65-374TEMPLATE1 report
- ATTUNE 2999-65-375TEMPLATE1 report
- ATTUNE 2999-65-381TEMPLATE1 report
- ATTUNE 2999-65-362TEMPLATE1 report
- ATTUNE 2999-65-364TEMPLATE1 report
- ATTUNE 2999-65-368TEMPLATE1 report
- ATTUNE 2999-66-157TEMPLATE1 report
- ATTUNE 2999-66-163TEMPLATE1 report
- ATTUNE 2999-66-169TEMPLATE1 report
- ATTUNE 2999-65-847TEMPLATE1 report
- ATTUNE 2999-65-716INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- ATTUNE 2999-65-466TEMPLATE1 report
- ATTUNE 2545-06-013TEMPLATE1 report
- ATTUNE 2545-06-014TEMPLATE1 report
- ATTUNE 2545-06-010TEMPLATE1 report
Recent ATTUNE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON STATED THE STYLUS WAS NOT CALIBRATED AND THAT THE BALANCER WAS STICKING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059792 ↗MalfunctionFeb 5, 2026Break; Scratched Material
IT WAS REPORTED THAT TIBIAL INSERTS HAD GOUGES/SCRATCHES DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273431 ↗MalfunctionFeb 5, 2026Break; Scratched Material
IT WAS REPORTED THAT TIBIAL INSERTS HAD GOUGES/SCRATCHES DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273424 ↗MalfunctionJan 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT BALANCE SIZER CAME APART IN PRE CASE SET UP, ALL COMPONENTS WERE TAKEN OUT OF CASE AND A NEW BALANCE SIZER WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192745 ↗MalfunctionDec 30, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE MTO BALANCED SIZER NO LONGER FUNCTIONS PROPERLY. THIS WAS DISCOVERED DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE. THE SURGEON STILL MANAGED TO USE THE INSTRUMENT SO THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926144 ↗MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT LUG DRILL STUCK IN HOLE OF FEMORAL TRIAL. BOTH PIECES NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23750605 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEMORAL SIZER WAS UNABLE TO HOUSE THE SIZER STYLUS CYLINDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708647 ↗MalfunctionAug 11, 2025Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT AFTER THE SURGERY IT WAS NOTICED THAT THE CEMENT BONDED IN BETWEEN THE TIGHTENING BOLT AND THE TOWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769910 ↗MalfunctionJul 24, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BALANCE SIZER WOULD NOT LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22591212 ↗MalfunctionJun 26, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE STUCK IN NOTCH SIZER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340863 ↗MalfunctionJun 18, 2025Break; Break
IT WAS REPORTED THAT THE MTO BALANCER WELD BROKE AND INSTRUMENT COMPLETELY FELL APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282249 ↗MalfunctionJun 17, 2025Break; Break
IT WAS REPORTED THAT THE MTO BALANCER WELD BROKE AND INSTRUMENT COMPLETELY FELL APART. THERE WAS UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235307 ↗MalfunctionJun 10, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE FIRST ATTUNE BALANCER LOCKING LEVER IS LOOSE AND DOES NOT LOCK TIGHT ENOUGH. THE 2ND ATTUNE BALANCER BINDS UP UNDER TENSION PER THE SURGEONS ADVISORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176540 ↗MalfunctionJun 10, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT THE FIRST ATTUNE BALANCER LOCKING LEVER IS LOOSE AND DOES NOT LOCK TIGHT ENOUGH. THE 2ND ATTUNE BALANCER BINDS UP UNDER TENSION PER THE SURGEONS ADVISORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176456 ↗MalfunctionDec 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEM SIZER CYLINDER WILL NOT GO DOWN THE CR RIGHT FEMORAL SIZER.
Patient problems: Insufficient Information
MAUDE report 20832545 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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