ATTUNE 2506-30-304Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FEMORAL OFFSET ADAPTOR TRIAL 4MM · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 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 10603295477839), received between Oct 14, 2019 and Nov 15, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Corroded” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Corroded2
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
ATTUNE REV FEM 2MM OFFST TRL WAS DELIVERED TO CUSTOMER AND NEEDED TO BE REWASHED BY CUSTOMER BEFORE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145213 ↗MalfunctionAug 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOLT IS STUCK IN BETWEEN BOTH ATTUNE REV FEM BOX TRL SZ 6 AND ATTUNE REV FEM 4MM OFFST TRL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17551063 ↗MalfunctionJan 24, 2020Corroded; Corroded
ISSUE:- STAINING OF ATTUNE REVISION INSTRUMENT. STAINING OF THE DEEP ENGRAVED LETTERING AND NUMBERING. ALSO NOTED IS A BLUE COATING AS CAN BE SEEN IN THE WORD LEFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627519 ↗MalfunctionOct 14, 2019Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING LEFT IN PATIENT. NASHVILLE LOANER SET 4 - GENERAL FEMORAL PREP. APPEARED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9185013 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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