ATTUNE 2546-00-527Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FEMORAL STRAIGHT STEM WRENCH · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295496236), received between Sep 14, 2018 and Mar 31, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED DURING KNEE SURGERY. INTRAOPERATIVELY, THE SLEEVE AND FEMORAL COMPONENT WERE ASSEMBLED USING THE RETAINING CLIP INSTRUMENT, RESULTING IN THE INABILITY TO REMOVE THE INSTRUMENT FROM THE IMPLANTS. THIS NECESSITATED THE USE OF ANOTHER SET OF IMPLANTS, CAUSING A SURGICAL DELAY OF APPROXIMATELY 45 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744224 ↗MalfunctionJul 1, 2024Break; Break
IT WAS REPORTED THAT THE CLAMP IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643209 ↗MalfunctionJan 2, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE WRENCH TOOTH BROKE AND DOESN'T FIT ON THE STEM. THE ROD CAP IS BENT AND DOESN'T SIT FLUSH ON THE FEMUR. ALL ITEMS DISCARDED BY SITE, NO RETURN AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18425078 ↗MalfunctionSep 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE TIGHTENING SCREW IS CROSS THREADED OR FROZEN IN PLACE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7876664 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 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.
How reports and recalls are matched · Editorial policy · Report an error on this page