ATTUNE 2545-05-550Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM ANATOMIC PATELLA CLAMP BUTTON · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE anatomic patella button is a small plastic button used during knee replacement surgery to help position the kneecap. The 54 reports mostly describe the button breaking, cracking or deforming, coming apart during the trial fitting stage of surgery, or wearing down so it no longer stays in place; most mention no lasting effect on the patient. There are no deaths and 1 injury. No recalls name 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
- 54
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295477150), received between Mar 9, 2020 and Jan 20, 2026 — classified as 1 injury, 53 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (19 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
- Device-Device Incompatibility19
- Naturally Worn16
- Break13
- Crack10
- Material Deformation8
- Device Slipped1
- Material Integrity Problem1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient9
- Insufficient Information4
- No Code Available1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Device-Device Incompatibility
PATELLA BUTTONS WILL NOT RETAIN. CUSTOMER REFERENCE/PO/SERVICE: ASG PATELLA BUTTON. PATIENT STATUS/ OUTCOME / CONSEQUENCES;. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THE DATE OF EVENT WAS UNKNOWN. THE ISSUE HAS PROGRESSED OVER TIME WITH WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114669 ↗MalfunctionJan 20, 2026Device-Device Incompatibility
PATELLA BUTTONS WILL NOT RETAIN CUSTOMER REFERENCE/PO/SERVICE --> ASG PATELLA BUTTON, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN THE DATE OF EVENT WAS UNKNOWN. THE ISSUE HAS PROGRESSED OVER TIME WITH WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114650 ↗MalfunctionJan 20, 2026Device-Device Incompatibility
PATELLA BUTTONS WILL NOT RETAIN. CUSTOMER REFERENCE/PO/SERVICE: ASG PATELLA BUTTON. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THE DATE OF EVENT WAS UNKNOWN. THE ISSUE HAS PROGRESSED OVER TIME WITH WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114638 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT PART OF THE PATELLA BUTTON TORE OFF DURING THE TRIALING PHASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831212 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560567 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556342 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556336 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556333 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555902 ↗MalfunctionSep 9, 2025Crack; Crack
IT WAS REPORTED THAT THERE WAS A CRACK THAT DEVELOPED DURING COMPRESSION OF THE IMPLANT. THERE WAS NO DELAY OF CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005465 ↗MalfunctionJul 1, 2025Break; Break
IT WAS REPORTED THAT WHILE CLOSING THE KNEE WOUND, THE MODULAR METAL PATELLA CLAMPING ATTACHMENT AND THE GREY ANATOMIC PLASTIC CLAMPING ATTACHMENT WERE LEFT IN THE PATIENT. THIS HAPPENED WHEN THE SURGICAL ASSIST AND SURGEON RELEASED THE LOCKING MECHANISM ON THE PATELLA CLAMP ARMS. UPON UNLOCKING OF THE CLAMP, THE TWO PIECES FELL OFF OF THE CLAMP AND INTO THE WOUND. NO PIECES BROKE DURING THIS EVENT. THE PIECES FELL OFF DUE TO THEIR MODULARITY AND THE SPRING ACTION OF THE LOCKING AND UNLOCKING MECHANISM ON THE PATELLA CLAMP. NO PERSON OR PARTY IN THE ROOM REALIZED THIS HAD HAPPENED. THE SURGICAL STAFF FINISHED CLOSING THE WOUND, UNKNOWING OF THE TWO PIECES STILL IN THE WOUND. ULTIMATELY THE PATIENT HAD TO BE BROUGHT BACK FOR A SEPARATE CASE TO HAVE THE INSTRUMENTS REMOVED. THE TWO ITEMS WERE THEN RETRIEVED FROM THE WOUND SAFELY. THIS COMPLAINT IS RELATED (B)(4) WHICH REPORTS THE POST OP REMOVAL SURGERY WHERE THE INSTRUMENTS WERE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373420 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT THE PLASTIC IS SPLIT PREOPERATIVELY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447879 ↗MalfunctionFeb 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT AN ATOMIC BUTTON IS TORN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21414354 ↗MalfunctionJan 3, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ANATOMIC PATELLA BUTTON HAS SLIGHTLY MELTED IN THE AUTOCLAVE AND HAS DEFORMED THE HOLES ON THE BACK. IT WILL NO LONGER STAY ON THE PATELLA BUTTON HOLDER. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21067341 ↗MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT A SAW WAS ACCIDENTALLY USED TO CLEAN UP BONE AND SHREDDED THE ATTUNE AN ATOMIC BUTTON. THE ARTICULATING SURFACE SNAPPED IN HALF WHEN REMOVING FROM THE KNEE. ALL PIECES WERE REMOVED AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846492 ↗MalfunctionNov 4, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2024. THE RUBBER PATELLA CLAMP WAS NOT STAYING IN THE MODULAR CLAMP PIECE.
Patient problems: Insufficient Information
MAUDE report 20601064 ↗MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN. NO PATIENT CONSEQUENCE OR DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470379 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE PIECES HAVE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19700399 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS WORN AND NO LONGER PROVIDED PROPER PRESSURE ON PATELLA IMPLANT. A SLIGHT DELAY AS THE SURGEON HAS TO CONTINUE READJUST THE CLAMP TO APPLY PROPER PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597131 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE RUBBER ANATOMIC PATELLA CLAMP IS DEFORMED AND WILL NOT COMPRESS PATELLA TO BONE WHILE CEMENTING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? 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 18597123 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS WORN AND NO LONGER PROVIDED PROPER PRESSURE ON PATELLA IMPLANT. A SLIGHT DELAY AS THE SURGEON HAS TO CONTINUE READJUST THE CLAMP TO APPLY PROPER PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597112 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS WORN AND NO LONGER PROVIDED PROPER PRESSURE ON PATELLA IMPLANT. A SLIGHT DELAY AS THE SURGEON HAS TO CONTINUE READJUST THE CLAMP TO APPLY PROPER PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597104 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS WORN AND NO LONGER PROVIDED PROPER PRESSURE ON PATELLA IMPLANT. A SLIGHT DELAY AS THE SURGEON HAS TO CONTINUE READJUST THE CLAMP TO APPLY PROPER PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597083 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE RUBBER ANATOMIC PATELLA CLAMP IS DEFORMED AND WILL NOT COMPRESS PATELLA TO BONE WHILE CEMENTING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? 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 18597068 ↗MalfunctionJan 25, 2023Material Integrity Problem; Material Integrity Problem
SURGERY AND PATIENT NOT IMPACTED. DAMAGED TODAY BY STERILE SERVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16239495 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 reports
- NA 03.111.022Synthes GmbH · INSTRUMENT, COMPRESSION17 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.
How reports and recalls are matched · Editorial policy · Report an error on this page