ATTUNE 2545-05-551Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM MED DOME 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 knee system component is a small clamp button used to hold parts of the knee implant in place during surgery. The 34 reports mostly describe the rubber or plastic clamp breaking, cracking or splitting, sometimes during surgery and sometimes when being cleaned after surgery. No deaths and no injuries are reported, and most cases finished without harm to the patient. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295477181), received between Feb 14, 2019 and Aug 28, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (25 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
- Break25
- Crack6
- Device-Device Incompatibility3
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient8
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Crack
It was reported that the black attune medial dome patella button clamp was cracked and needs to be replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498113 ↗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 24393752 ↗MalfunctionFeb 13, 2026Break
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY SURGERY, THE POLY TRIAL SPRING WAS MISSING AND THE PATELLA CLAMP BUTTON ATTACHMENT WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333819 ↗MalfunctionFeb 13, 2026Break
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY SURGERY THE POLY TRIAL SPRING WAS MISSING AND THE PATELLA CLAMP BUTTON ATTACHMENT WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333816 ↗MalfunctionJan 23, 2026Crack
PATELLA DOME CLAMP CRACKING. SHIM NOT ATTACHING TO TRIAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO PATIENT INVOLVEMENT. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (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 24159547 ↗MalfunctionDec 22, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA RUBBER CLAMP SPLIT ON TWO SETS. NOTICED IN CASE. NO ADVERSE EFFECTS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864820 ↗MalfunctionDec 22, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA RUBBER CLAMP SPLIT ON TWO SETS. NOTICED IN CASE. NO ADVERSE EFFECTS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864819 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THE RUBBER BUTT SPLIT DURING REMOVAL FOR CLEANING. EVENT WAS NOT DURING A CASE SO NO IMPACT. THE SET WAS REMOVED FROM CIRCULATION UNTIL REPLACEMENT ARRIVES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423470 ↗MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE DOME BUTTON COMES OFF WHEN TRYING TO USE IT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22884917 ↗MalfunctionJul 3, 2025Break; Break
IT WAS REPORTED THAT THE RUBBER IS PEELING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396878 ↗MalfunctionJun 16, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA SQUEEZER RIPPED DURING CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213384 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT THE FB FLOATING EVAL BULLET WAS BENT AND THE BLACK PATELLA CLAMP BUTTON TORE IN HALF.
Patient problems: Insufficient Information
MAUDE report 21971028 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT THE FB FLOATING EVAL BULLET WAS BENT AND THE BLACK PATELLA CLAMP BUTTON TORE IN HALF.
Patient problems: Insufficient Information
MAUDE report 21971027 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT THE FB FLOATING BULLET WAS BENT AND WILL NO LONGER FIT IN TIBIAL TRAY APPROPRIATELY. ALSO, THE BLACK PATELLA BUTTON FOR THE CLAMP WAS TORN IN HALF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21959540 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT THE FB FLOATING BULLET WAS BENT AND WILL NO LONGER FIT IN TIBIAL TRAY APPROPRIATELY. ALSO, THE BLACK PATELLA BUTTON FOR THE CLAMP WAS TORN IN HALF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21959436 ↗MalfunctionApr 30, 2025Crack; Crack
IT WAS REPORTED THAT A CLAMP BROKE DURING KNEE SURGERY. THERE WAS NO HARM TO THE PATIENT, NO DELAYS TO SURGERY AND THE INSTRUMENT DID NOT BREAK IN TWO. THE RUBBER IS WARN/SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934560 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT THE PLASTIC IS SPLIT PREOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447848 ↗MalfunctionJan 6, 2025Crack; Crack
IT WAS REPORTED THAT THE PLASTIC PATELLA BUTTON FROM THE CLAMP CRACKED.
Patient problems: Insufficient Information
MAUDE report 21079014 ↗MalfunctionAug 12, 2024Crack; Crack
PATELLA BUTTON IMPACTOR RUBBER IS CRACKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959864 ↗MalfunctionAug 12, 2024Crack; Crack
PATELLA BUTTON IMPACTOR RUBBER IS CRACKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959863 ↗MalfunctionJun 14, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO HARM. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY. C. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? ALL PIECES RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19536115 ↗MalfunctionNov 28, 2023Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE ATTUNE MED DOME PAT CLAMP BUT IS DAMAGED AND IS SLIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18222306 ↗MalfunctionOct 16, 2023Break; Break
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE PLASTIC ATTUNE DOME PATELLA BUTTON HOLDER RIPPED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17939780 ↗MalfunctionAug 25, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ONE OF THE PEGS BROKE ON THE TRIAL AND THE RUBBER PATELLA CLAMP WOULD NOT STAY IN THE METAL BACKING. A TEAR WAS DISCOVERED AT THE PEG PART OF THE RUBBER CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17623897 ↗MalfunctionMay 8, 2023Break; Break
THE BLACK RUBBER PIECE THAT HELPS IN HOLDING THE DOME PATELLA, DURING CEMENTING WAS SLIGHTLY RIPPED, AFTER THE CASE. THIS HAD ZERO EFFECT ON THE CASE OR TIME OF THE CASE. ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THE MALFUNCTION OF BOTH THE PATELLA CLAMP AND TIBIAL IMPACTOR HAPPENED IN THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16888072 ↗
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
- 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.
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