ATTUNE 2545-05-552Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM PATELLA CLAMP BUTTON HOLDER · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE patella clamp button holder is an instrument used with patella buttons during knee surgery. The 26 reports mostly describe incompatibility, parts breaking or wearing out, and the holder failing to lock onto or retain the button. There were no deaths or injuries, and no recalls name this device. Reports rose from 4 in the previous 12 months to 9 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295477198), received between May 29, 2018 and Sep 22, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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
- Device-Device Incompatibility11
- Break8
- Naturally Worn3
- Material Deformation2
- Material Twisted/Bent2
- Component Missing1
- Corroded1
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient8
- Insufficient Information3
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
It was reported that the event did not occur during a procedure. It was observed that metal broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849843 ↗MalfunctionAug 27, 2026No Apparent Adverse Event
It was reported that the impacted product had an unknown allegation. It did not happened in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482859 ↗MalfunctionFeb 19, 2026Device-Device Incompatibility
BLACK BUTTON NOT LOCKING ONTO HOLDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24393753 ↗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 24115125 ↗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 24114940 ↗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 24114922 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569712 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569711 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569709 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569702 ↗MalfunctionJul 8, 2025Corroded; Corroded
IT WAS REPORTED THAT INSTRUMENTS WERE RUSTY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22440310 ↗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 22373424 ↗MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED, THAT THE PATELLA CLAMP PIECE WAS STRIPPED AND WOULDN¿T STAY ON THE CLAMP, DURING THE CASE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20673698 ↗MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE PATELLA CLAMP PIECE WAS STRIPPED AND WOULDN¿T STAY ON THE CLAMP DURING THE CASE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20673603 ↗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 20470432 ↗MalfunctionSep 15, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HOLDER IS WORN AND NEEDS REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474139 ↗MalfunctionSep 15, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HOLDER IS WORN AND NEEDS REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474138 ↗MalfunctionJul 30, 2021Break; Break
IT WAS REPORTED THAT THE PAD WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253035 ↗MalfunctionMar 8, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE METAL MODULAR BACKING FOR THE PATELLA CLAMP DOES NOT SLIDE ONTO THE PATELLA CLAMP. THERE IS A HARD STOP WHEN FIRST FITTING THE PIECE ON. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440147 ↗MalfunctionOct 22, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP AND PATELLA BUTTON WOULD NOT STAY ENGAGED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10721708 ↗MalfunctionMay 28, 2020Device Slipped; Naturally Worn; Device Slipped; Naturally Worn
IT WAS REPORTED THAT THE BUTTON AND BUTTON HOLDER WILL NOT ATTACH. THEY HAVE GOTTEN WORN AND SLIP LOOSE NOW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10097721 ↗MalfunctionMay 21, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN TRYING TO DRILL HOLES FOR THE PATELLA, THE BUTTON WOULD NOT STAY ATTACHED. LOOKS AS IF THE BALL BERING HAS FAILED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10081099 ↗MalfunctionDec 11, 2019Material Twisted/Bent; Material Twisted/Bent
REPLACEMENT OF OLD STYLE PATELLA SQUEEZER FOR ATTUNE REQUIRED, COMPLAINT FROM CUSTOMER WAS THAT THE ORANGE VERSION WAS CONSTANTLY TEARING WHEN REMOVED FOR CLEANING
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9452779 ↗MalfunctionDec 11, 2019Material Twisted/Bent; Material Twisted/Bent
REPLACEMENT OF OLD STYLE PATELLA SQUEEZER FOR ATTUNE REQUIRED, COMPLAINT FROM CUSTOMER WAS THAT THE ORANGE VERSION WAS CONSTANTLY TEARING WHEN REMOVED FOR CLEANING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9452764 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
BUTTON HOLDER DOES NOT STAY ON HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240795 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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