ATTUNE 2545-01-040Recalls & reported problems
Depuy (Ireland) · ATTUNE PATELLA RESECTION GUIDE · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune patella resection guide is a surgical instrument used in knee replacement to help shape the kneecap. The 59 reports mostly describe problems with the instrument itself — scratched surfaces, peeling or damaged metal coating, residue left after cleaning, parts wearing out or breaking, and fit issues with other instruments. No deaths or injuries are reported. There are no recalls naming this device. Reports rose sharply, from 3 in the previous 12 months to 22 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
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295395430), received between Sep 21, 2018 and Aug 6, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (14 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material14
- Contamination /Decontamination Problem12
- Device-Device Incompatibility9
- Naturally Worn8
- Peeled/Delaminated8
- Break5
- Material Deformation5
- No Apparent Adverse Event5
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Consequences Or Impact To Patient7
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155982 ↗MalfunctionAug 6, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155956 ↗MalfunctionAug 6, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155882 ↗MalfunctionJul 31, 2026Contamination /Decontamination Problem
IT was reported that Attune patellar forceps apparently have a "lubricating film" after the cleaning process in CSSD. There was no reported patient or user harm. There was no significant delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101907 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225796 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225720 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225612 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225577 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225517 ↗MalfunctionJan 30, 2026No Apparent Adverse Event
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225476 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225411 ↗MalfunctionJan 30, 2026No Apparent Adverse Event
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225346 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225156 ↗MalfunctionJan 30, 2026Peeled/Delaminated
IT WAS REPORTED MULTIPLE PATELLA RESECTION INSTRUMENT'S METAL COATING WAS DAMAGED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225129 ↗MalfunctionJan 30, 2026No Apparent Adverse Event
PATELLA RESECTION INSTRUMENT VERY USED, METAL COATING DAMAGED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO, 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. NONE, DEVICE IN POSSESSION OF. NONE. 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 24220962 ↗MalfunctionJan 30, 2026No Apparent Adverse Event
PATELLA RESECTION INSTRUMENT VERY USED, METAL COATING DAMAGED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. 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: NONE. DEVICE IN POSSESSION OF: NONE. 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 24220959 ↗MalfunctionJan 30, 2026No Apparent Adverse Event
PATELLA RESECTION INSTRUMENT VERY USED, METAL COATING DAMAGED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. 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: NONE. DEVICE IN POSSESSION OF: NONE. 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 24220939 ↗MalfunctionJan 15, 2026Scratched Material
IT WAS REPORTED THAT SEVERAL ATTUNE PATELLAR CLAMPS WERE WORN WITH MULTIPLE SAW BLADE MARKS. ACCORDING TO THE REPORTER, THE USER FACILITY DEEMED THIS A STERILITY ISSUE AND WANT SEVERAL REPLACED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082136 ↗MalfunctionJan 15, 2026Scratched Material
IT WAS REPORTED THAT SEVERAL ATTUNE PATELLAR CLAMPS WERE WORN WITH MULTIPLE SAW BLADE MARKS. ACCORDING TO THE REPORTER, THE USER FACILITY DEEMED THIS A STERILITY ISSUE AND WANT SEVERAL REPLACED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082134 ↗MalfunctionJan 15, 2026Scratched Material
IT WAS REPORTED THAT SEVERAL ATTUNE PATELLAR CLAMPS WERE WORN WITH MULTIPLE SAW BLADE MARKS. ACCORDING TO THE REPORTER, THE USER FACILITY DEEMED THIS A STERILITY ISSUE AND WANT SEVERAL REPLACED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082129 ↗MalfunctionJan 15, 2026Scratched Material
IT WAS REPORTED THAT SEVERAL ATTUNE PATELLAR CLAMPS WERE WORN WITH MULTIPLE SAW BLADE MARKS. ACCORDING TO THE REPORTER, THE USER FACILITY DEEMED THIS A STERILITY ISSUE AND WANT SEVERAL REPLACED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082128 ↗MalfunctionJan 15, 2026Scratched Material
IT WAS REPORTED THAT SEVERAL ATTUNE PATELLAR CLAMPS WERE WORN WITH MULTIPLE SAW BLADE MARKS. ACCORDING TO THE REPORTER, THE USER FACILITY DEEMED THIS A STERILITY ISSUE AND WANT SEVERAL REPLACED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082118 ↗MalfunctionAug 26, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RATCHETING SYSTEM FOR THE PATELLA SAW GUIDE WAS NO LONGER RATCHETING AND DID NOT STAY CLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895778 ↗MalfunctionMay 1, 2025Improper or Incorrect Procedure or Method; Scratched Material; Improper or Incorrect Procedure or Method; Scratched Material
IT WAS REPORTED THAT THE SURGEON REMOVED THE TRIAL WITH A KOCHER¿S AND SCRATCHED THE TRIAL WITH THE TEETH OF THE INSTRUMENT. THIS HAS LEFT DEEP GROOVES IN THE TRIAL. A SMALL DELAY TO SURGERY WHILST A SECOND INSTRUMENT TRAY WAS OPENED. NO HARM TO THE PATIENT. SURGEON RECOGNIZED DEFECT PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21943850 ↗MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA RESECTION GUIDE IS NOT HOLDING POSITION CONSISTENTLY. SEEMS RATCHETING TEETH HAVE WORN DOWN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 21410658 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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