ATTUNE 2545-01-529Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM CEMENTLESS IMPACTION · 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 10603295457688), received between Nov 5, 2025 and Feb 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem2
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Peeled/Delaminated
MDR STATED THAT SOME OF THE PLASTIC WAS PEELING OFF THE PAN AND THEY WANTED IT REPLACED. NO PATIENT INCIDENT OR ISSUE, JUST NEEDED A NEW PAN. CEMENTLESS IMPACTION - 254501529 NOT APPLICABLE. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. NONE. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369479 ↗MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DAMAGED TRAYS WERE LOCATED IN SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479756 ↗MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DAMAGED TRAYS WERE LOCATED IN SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479750 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- Calibrate CLCCXSIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501A2Karl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 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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