ATTUNE 2545-01-708Recalls & reported problems
Depuy (Ireland) · ATTUNE PATELLA PREP · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE patella preparation tray is a surgical instrument tray used to prepare the kneecap during joint surgery. The 51 reports mostly describe the black coating peeling or flaking off the tray, sometimes leaving sharp edges, along with a few cracked or bent trays. No deaths and no injuries were reported. There are no recalls naming this device.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295423584), received between May 28, 2019 and May 5, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (36 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
- Peeled/Delaminated36
- Break3
- Crack2
- Device-Device Incompatibility1
- Illegible Information1
- Material Discolored1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient8
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC WAS PEELING OFF THE INSIDE OF THE TRAY. THERE WAS NO HARM TO PATIENT. THERE WAS NO DELAY. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081554 ↗MalfunctionApr 30, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC ON TRAY PEELING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045917 ↗MalfunctionApr 29, 2026Peeled/Delaminated
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE PATELLA TRAY LINING WAS FLAKING OFF AND BECOMING A STERILITY CONCERN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031249 ↗MalfunctionApr 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT PLASTIC WAS PEELING FROM THE INSIDE OF THE PAN. NO PATIENT HARM. NO DELAY IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002889 ↗MalfunctionApr 7, 2026Peeled/Delaminated
IT WAS REPORTED THAT TRAY WAS PEELING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24807703 ↗MalfunctionApr 6, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PATELLA PAN WAS PEELING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791379 ↗MalfunctionMar 31, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT IS PEELING FORM TRAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744940 ↗MalfunctionMar 10, 2026Peeled/Delaminated
IT WAS REPORTED THAT TRAY PLASTIC WAS PEELING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24558824 ↗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 24200439 ↗MalfunctionJan 27, 2026Peeled/Delaminated
PRINT ON TRAY IS COMING OFF PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF OTHER, DEVICE IN POSSESSION OFNONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192276 ↗MalfunctionDec 31, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PATELLA TRAY WAS STARTING TO PEEL AND NEEDED TO BE REPLACED. THE FEMORAL IMPACTOR BROKE DURING IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933164 ↗MalfunctionJul 21, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL WAS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THEY WERE ASKING FOR REPLACEMENTS FOR STERILIZATION REQUIREMENTS. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22556312 ↗MalfunctionJul 21, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL WAS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THEY WERE ASKING FOR REPLACEMENTS FOR STERILIZATION REQUIREMENTS. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22556265 ↗MalfunctionJan 27, 2025Peeled/Delaminated; Illegible Information; Peeled/Delaminated; Illegible Information
IT WAS REPORTED THAT AFTER THIS CASE WAS COMPLETED AND THE INSTRUMENTS HAD GONE THROUGH THE WASH OF STERILE PROCESSING IT WAS SEEN THAT ON THE SIDE OF THE PATELLA TRAY THAT THE BLACK WRITING OR LABELING WAS STARTING TO WEAR OFF. THIS TRAY NEEDS TO BE REPLACED. IT WAS REMOVED FROM CIRCULATION ONCE THIS WAS NOTICED. THERE WAS NO EFFECT TO THE PATIENT AND NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21242776 ↗MalfunctionDec 19, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS NOTICED THAT THE PANS WERE DELAMINATING IN SOME PLACES IN THE PAN. THE PLASTIC OR PAINT LAMINATE WAS COMING OFF IN SEVERAL PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20982047 ↗MalfunctionDec 19, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS NOTICED THAT THE PANS WERE DELAMINATING IN SOME PLACES IN THE PAN. THE PLASTIC OR PAINT LAMINATE WAS COMING OFF IN SEVERAL PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20982036 ↗MalfunctionAug 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INNER BLACK LINING IS PEELING OFF. HOSPITAL WILL NOT STERILIZE TRAY DUE TO THIS REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20008190 ↗MalfunctionMar 27, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICE PAN WAS PEELING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18989660 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE GRAPHIC INSTRUMENT CASES WERE FLAKING AND THE HOSPITAL DEEMED THE SETS CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913700 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED TO CONFIRM DELAYS IN SURGERY HAD OCCURED SO THE PROCEDURES HAD TO BE RESCHEDULED. NO REPORTED PATIENT HARMS AS OF YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913678 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED TO CONFIRM DELAYS IN SURGERY HAD OCCURED SO THE PROCEDURES HAD TO BE RESCHEDULED. NO REPORTED PATIENT HARMS AS OF YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913632 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED TO CONFIRM DELAYS IN SURGERY HAD OCCURED SO THE PROCEDURES HAD TO BE RESCHEDULED. NO REPORTED PATIENT HARMS AS OF YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913548 ↗MalfunctionMar 7, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY IS PEELING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18855566 ↗MalfunctionFeb 27, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY. NO PATIENT CONSEQUENCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18788339 ↗MalfunctionFeb 1, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT WAS PEELING ON TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18622706 ↗
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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