ATTUNE 2506-10-110Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL CUT BLOCK MOUNT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295436171), received between Jan 10, 2019 and Feb 26, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break3
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE REPORTED INSTRUMENTS WERE BENT. THE SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470457 ↗MalfunctionOct 12, 2022Break; Break
IT WAS REPORTED THE JIG LOCKING MECHANISM BROKEN, INFORMED BY STERILE SERVICES AS DISCOVERED BROKEN DURING CLEANING PROCESS. ITEM NOT USED DURING THE CASE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15587334 ↗MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility
DOES NOT TIGHTEN ONTO 250610112.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9233984 ↗MalfunctionMay 24, 2019Break; Break
IT WAS REPORTED THAT THE ATTUNE REV TIBIAL CUTTING BLOCK MOUNT WAS BROKEN UPON ARRIVING. IT WILL NOT LOCK ONTO CUTTING BLOCK AS INTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8641447 ↗MalfunctionMar 20, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE ATTUNE REV TIB CUT BLCK MOUNT DOES NOT TIGHTEN ONTO ATTUNE REV TIBIAL BLOCK R.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8437248 ↗MalfunctionJan 10, 2019Break; Break
IT WAS REPORTED THAT THE ATTUNE REVISION TIBIA CUTTING BLOCK MOUNT. WOULD NOT LOCK ONTO THE TIBIAL CUTTING BLOCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8236733 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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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