ATTUNE 2546-00-106Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FEMORAL BROACH STOP RIGHT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295450924), received between Feb 7, 2019 and Aug 22, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.
Most reported problems
Device problems
- Device-Device Incompatibility3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE GUIDE KEPT SLIDING UP WHEN BROACH HANDLE WAS BEING IMPACTED. LOCKING MECHANISM SEEMS FAULTY. NO HARM TO PATIENT OR DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597429 ↗MalfunctionFeb 7, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED TWO BROACH HANDLES WERE NOT CATCHING AND A BROACH STOP RIGHT WAS VIBRATING OFF THE HANDLE DURING USE. THE ISSUE OCCURRED DURING SURGERY ON (B)(6) 2019. THE FEMORAL BROACH WAS LODGED IN THE FEMORAL CANAL, WITH THE SURGEON UNABLE TO REMOVE IT. BOTH BROACH HANDLES WERE USED, BUT HE COULDN'T GET THE BROACH DISLODGED. A DIFFERENT INSTRUMENT WAS USED TO GET THE BROACH OUT. SURGERY WAS EXTENDED BY ABOUT FIFTEEN (15) MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8316248 ↗MalfunctionFeb 7, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED TWO BROACH HANDLES WERE NOT CATCHING AND A BROACH STOP RIGHT WAS VIBRATING OFF THE HANDLE DURING USE. THE ISSUE OCCURRED DURING SURGERY ON (B)(6) 2019. THE FEMORAL BROACH WAS LODGED IN THE FEMORAL CANAL, WITH THE SURGEON UNABLE TO REMOVE IT. BOTH BROACH HANDLES WERE USED, BUT HE COULDN¿T GET THE BROACH DISLODGED. A DIFFERENT INSTRUMENT WAS USED TO GET THE BROACH OUT. SURGERY WAS EXTENDED BY ABOUT FIFTEEN (15) MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8316220 ↗
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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.
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