ATTUNE 2545-01-023Recalls & reported problems
Depuy (Ireland) · ATTUNE PATELLA WAFER SMALL · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295136002), received between Sep 4, 2024 and Nov 17, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569721 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569716 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569713 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569710 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569708 ↗MalfunctionSep 4, 2024Break; Break
IT WAS REPORTED THAT THE PATELLA WAFER SPIKE BROKEN ATTACH CLAMPING TO PATELLA, TIB IMPACTOR WAS BROKEN WHILE IMPACTING PRESS FIT TIB. 38 PATELLA PRIORLY WON'T STUCK INTO PATIENT CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 20134233 ↗MalfunctionSep 4, 2024Break; Break
IT WAS REPORTED THAT THE PATELLA WAFER SPIKE BROKE WHEN CLAMPING TO PATELLA, TIBIAL IMPACTOR BROKE WHILE IMPACTING PRESS FIT TIBIA, 38 PATELLA PRIORY WON'T CONNECT IN TO THE PATELLA CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 20134157 ↗
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- 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.
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