ATTUNE 2547-07-001Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION DISTAL FEMORAL AUGMENT TRIAL 4MM X SIZE 7-8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295439448), received between Aug 24, 2018 and Jul 8, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Corroded” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Corroded6
- Appropriate Device Problem Term/Code Not Available2
- Device Contamination with Chemical or Other Material2
- Break1
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE STERILIZATION DEPARTMENT OF THE HOSPITAL SAW DURING INSPECTION OF THE INSTRUMENTS SOME STAINS ON SEVERAL THE INSTRUMENTS FOR AUGMENTATION (DISTAL & POSTERIOR) OF THE FEMORAL COMPONENT. IT LOOKS LIKE THERE IS SOME RUST FORMATION ON THE EDGE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436577 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, AND THE AUGMENT WAS BROKEN. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759165 ↗MalfunctionJul 22, 2022Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15086004 ↗MalfunctionJul 22, 2022Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15085987 ↗MalfunctionOct 14, 2019Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING WAS LEFT IN PATIENT. NASHVILLE LOANER SET 4 GENERAL FEMORAL PREP CONTINUED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9185028 ↗MalfunctionOct 14, 2019Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9185018 ↗MalfunctionJan 25, 2019Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material
IN DEPUY LOANER DEPARTMENT METAL DEBRIS WAS SEEN ON FEMUR AUGMENTS OF THE ATTUNE REVISION SETS. ALL AUGMENTS WERE AFFECTED BUT DIFFERENT DEGREES. THE INSTRUMENTATION WAS READY PACKED FOR SHIPMENT. THE INSTRUMENTATION WAS SHIPPED A TOTAL OF 8 TIMES AND WAS THOROUGHLY CLEANED 3 TIMES WITH ALCOHOL BY AN ORTHOKIT OPERATOR. IN ADDITION, THERE ARE NOTICEABLE RUST MARKS, PROBABLY FROM THE ENGRAVING. THIS WAS SEEN INTERNALLY; NO PATIENT INVOLVEMENT, NO SURGERY DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8278961 ↗MalfunctionJan 25, 2019Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material
IN DEPUY LOANER DEPARTMENT METAL DEBRIS WAS SEEN ON FEMUR AUGMENTS OF THE ATTUNE REVISION SETS. ALL AUGMENTS WERE AFFECTED BUT DIFFERENT DEGREES. THE INSTRUMENTATION WAS READY PACKED FOR SHIPMENT. THE INSTRUMENTATION WAS SHIPPED A TOTAL OF 8 TIMES AND WAS THOROUGHLY CLEANED 3 TIMES WITH ALCOHOL BY AN ORTHOKIT OPERATOR. IN ADDITION, THERE ARE NOTICEABLE RUST MARKS, PROBABLY FROM THE ENGRAVING. THIS WAS SEEN INTERNALLY; NO PATIENT INVOLVEMENT, NO SURGERY DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8278951 ↗MalfunctionAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
TRIAL SHOWS MAGNETIC/METAL WEAR BEFORE USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7814257 ↗MalfunctionAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
TRIAL SHOWS MAGNETIC/METAL WEAR BEFORE USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7814250 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page