ATTUNE 2544-01-009Recalls & reported problems
Depuy (Ireland) · ATTUNE FIXED BEARING INSERT IMPACTOR · Class 1
Quick summary
This DePuy ATTUNE fixed bearing insert impactor is a surgical instrument used to press implants into place during hip or knee procedures. Most of the 28 reports describe the instrument breaking during surgery, sometimes into several pieces, along with scratched or cracked surfaces and contamination. No deaths or 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295395423), received between Oct 5, 2018 and Aug 11, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break21
- Contamination /Decontamination Problem2
- Crack2
- Scratched Material2
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient5
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Break
It was reported that the impacted product was broken during case.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213348 ↗MalfunctionMay 11, 2026Scratched Material
IT WAS REPORTED THAT FIXED BEARING IMPACTOR HAS AN ABRASION ON THE END OF INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136666 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT TIBIA IMPACTOR BROKE INTO FOUR PIECES, ALL PIECES WERE FOUND AND ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209837 ↗MalfunctionFeb 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO SURGICAL DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364479 ↗MalfunctionJan 14, 2025Break; Break
IT WAS REPORTED THAT IMPACTOR BROKE DURING IMPACTION. NO INJURIES WERE CREATED. THE BROKEN IMPACTOR WAS DISCARDED. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21151284 ↗MalfunctionJan 14, 2025Break; Break
IT WAS REPORTED THAT IMPACTOR BROKE DURING IMPACTION. NO INJURIES WERE CREATED. THE BROKEN IMPACTOR WAS DISCARDED. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21151157 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL MEASURED SIZER HAD A BROKEN PIN HOLE AND WAS NOT USED APPROPRIATELY DUE TO INSTRUMENT MALFUNCTION. THE FEMORAL SIZER HANDLE HAD THE PIN HOLE COME OUT WHEN PIN WAS BEING INSERTED. PART OF THE THE FB INSERT IMPACTOR WAS CHIPPED AND NEEDED TO BE REPLACED. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111717 ↗MalfunctionMay 22, 2024Break; Break
IT WAS REPORTED THAT THE INSERT IMPACTOR TIP WAS CHIPPED.
Patient problems: Insufficient Information
MAUDE report 19370620 ↗MalfunctionMay 22, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 19370177 ↗MalfunctionDec 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT IMPACTOR TIP BROKE. NO FRAGMENTS WERE CREATED, ALL PIECES WERE FOUND AND DISCARDED. 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, (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 18302365 ↗MalfunctionDec 4, 2023Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18263656 ↗MalfunctionSep 5, 2023Break; Break
THE TIP OF THE INSERT IMPACTOR HAS THE IMPACTION DAMAGE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. 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, (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 17686807 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT THE HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17642846 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT THE FB INSERT IMPACTOR IS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596221 ↗MalfunctionMay 16, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGERY WAS PERFORMED VIA TKA WITH THE PRODUCT IN QUESTION. THE PRODUCT IN QUESTION WAS DAMAGED DURING THE PLACEMENT OF AN ATTUNE TIBIAL IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16937679 ↗MalfunctionApr 24, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE FB IMPACTOR CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16794714 ↗MalfunctionJul 28, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE OFF. NO PARTS WERE EFT IN PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15122243 ↗MalfunctionJun 2, 2022Crack; Naturally Worn; Crack; Naturally Worn
INSTRUMENT CRACKED AT THE BASE BUT NOT INTO TWO PIECES. NO LONGER USEABLE FROM WEAR AND TEAR. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14578371 ↗MalfunctionOct 26, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12698747 ↗MalfunctionOct 19, 2021Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT WHILE CLEANING OVERTIME, SPD HAS SCRATCHED THE INSTRUMENTS AND CEMENT CANT BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12656120 ↗MalfunctionFeb 21, 2020Break; Break
IT WAS REPORTED THAT THE RP TIBIAL IMPACTOR BROKE INTO TWO PIECES WHEN IMPACTING THE TIBIA. NO PIECES WERE LEFT IN THE PATIENT. IMPACTOR BROKE INTO TWO LARGE PIECES. THIS DID NOT DELAY SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9738880 ↗MalfunctionJan 23, 2020Break; Break
THE FB TIBIAL IMPACTOR BROKE IN HALF DURING IMPLANTATION OF THE TIBIAL TRAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9621578 ↗MalfunctionJun 21, 2019Break; Break
IT WAS REPORTED THAT THE TIBIAL IMPACTOR WAS BROKEN WHEN USING MALLET. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8724111 ↗MalfunctionMay 23, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE TIBIAL INSERT IMPACTOR (P/N: 254401009) WAS BROKEN DURING THE TKA SURGERY ON (B)(6) 2019. THE TIP OF THE TIBIAL INSERT IMPACTOR WAS CRACKED RIGHT IN HALF WHEN THE SURGEON ATTEMPTED TO INSERT THE TIBIAL TRAY. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8638024 ↗MalfunctionOct 5, 2018Break; Break
HANDLE AND TIP BROKEN DURING TIBIAL COMPONENT IMPACTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7937956 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.