ATTUNE 2545-01-714Recalls & reported problems
Depuy (Ireland) · ATTUNE PATELLA PREP (GEN 2) · Class 1
Quick summary
This is a DePuy ATTUNE Patella Prep tray, a reusable surgical tray for instruments used in kneecap preparation. Most of the 32 reports describe the tray's plastic peeling or delaminating, plus cracks, breaks, and paint flaking off; in several cases sterile processing would not accept the tray for reuse. No deaths or injuries were reported, and no recalls name this device. Reports fell from 22 in the earlier 12-month period to 6 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295442936), received between Feb 21, 2023 and Sep 30, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (46 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated46
- Crack11
- Break8
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944324 ↗MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944320 ↗MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944314 ↗MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944311 ↗MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944299 ↗MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944280 ↗MalfunctionSep 30, 2026Peeled/Delaminated
It was reported that the black plastic on the inside of the trays is delaminating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944270 ↗MalfunctionSep 28, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921099 ↗MalfunctionSep 28, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921060 ↗MalfunctionSep 28, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921031 ↗MalfunctionSep 28, 2026Peeled/Delaminated
It was reported that the black plastic inside the trays was delaminating. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920978 ↗MalfunctionSep 28, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920931 ↗MalfunctionSep 28, 2026Peeled/Delaminated
It was reported that the black plastic inside the trays was delaminating. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920809 ↗MalfunctionSep 28, 2026Peeled/Delaminated
It was reported that the black plastic inside the trays was delaminating. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920760 ↗MalfunctionSep 28, 2026Peeled/Delaminated
It was reported that the black plastic inside the trays was delaminating. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920755 ↗MalfunctionSep 28, 2026Peeled/Delaminated
It was reported that the black plastic inside the trays was delaminating. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920700 ↗MalfunctionSep 28, 2026Peeled/Delaminated
It was reported that the black plastic inside the trays was delaminating. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920523 ↗MalfunctionMay 6, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC WAS COMING OFF THE I SIDE OF THE TRAY AND STERILE PROCESSING (SPD) WOULD NOT PROCESS IT. NO DELAY, NO HARM TO PATIENT, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25091938 ↗MalfunctionMay 5, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC PEELED OFF FROM INSIDE THE PAN AND STERILE PROCESSING DEPARTMENT WOULD NOT STERILIZE IT. NO DELAY. NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086300 ↗MalfunctionJan 28, 2026Peeled/Delaminated
PATELLA PREP TRAYS HAVE BURNS ON THE INSIDE OF THE TRAY AND PAINT WAS FLAKING OFF ON THE EXTERIOR OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200441 ↗MalfunctionJan 28, 2026Peeled/Delaminated
PATELLA PREP TRAYS HAVE BURNS ON THE INSIDE OF THE TRAY AND PAINT WAS FLAKING OFF ON THE EXTERIOR OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200424 ↗MalfunctionJan 28, 2026Peeled/Delaminated
PATELLA PREP TRAYS HAVE BURNS ON THE INSIDE OF THE TRAY AND PAINT WAS FLAKING OFF ON THE EXTERIOR OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200423 ↗MalfunctionJul 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE DEVICE WAS PEELING AND SCRATCHED. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22543965 ↗MalfunctionJul 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENTS WERE PEELING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398466 ↗MalfunctionJul 2, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT TRAY CHIPPING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22386762 ↗
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
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.