ATTUNE 2546-00-453Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE · 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 10603295440277), received between Sep 14, 2020 and Dec 18, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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
- Device-Device Incompatibility4
- Mechanical Jam1
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.
MalfunctionDec 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THE ORIGINAL IMPLANTS WERE INFECTED. THE SURGEON REVISED THE FEMORAL SIDE.
Patient problems: Insufficient Information
MAUDE report 20969235 ↗MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEMORAL SLEEVE SEPARATOR BASE DIDN'T SEEM TO EVER THREAD INTO THE FEMUR CORRECTLY AND WOULD PULL OFF PRIOR TO DISENGAGEMENT. TIBIAL SLEEVE SEPARATOR BASE AND TIBIAL SLEEVE SEPARATOR WEDGE STAYED ATTACHED TO THE TIBIAL TRAY. THE THREADS WERE STRIPPED ON THE TAPER BASE. THERE WAS A SURGICAL DELAY OF 2 HOURS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915860 ↗MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility
TIBIAL EXTRACTION SLEEVE EXTRACTION DEVICE GOT STUCK ONTO THE TIBIAL TRAY AND STEM CONSTRUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13077973 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT ATTUNE PARTS WERE COLD WELDED TOGETHER AND CAN'T GET THEM SEPARATED. USED IN SURGERY TO GET OUT ATTUNE REVISION KNEE. TRIED TO SEPARATE THEM AFTER CASE AND THEY WON'T COME APART.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10531835 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 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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