NA 9200-10-028Recalls & reported problems
Depuy (Ireland) · DePuy MI System IMPACTOR TIP 36mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy impactor tip is a surgical instrument used to seat hip replacement liners during hip replacement surgery. Most of the 50 reports describe the tip breaking, often into two pieces, while the surgeon was impacting the implant; in the reports reviewed, all pieces were retrieved and surgery continued without delay or harm. There are no deaths and no injuries. 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
- 50
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10603295221883), received between Oct 11, 2017 and Feb 3, 2026 — classified as 50 malfunctions.
The most frequently reported specific device problem is “Break” (49 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
- Break49
- Device-Device Incompatibility2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient10
- Insufficient Information3
- No Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT THE 36 MM IMPACTOR TIP BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED. NO DELAY OR ADVERSE EVENT OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248044 ↗MalfunctionOct 22, 2025Break; Break
IT WAS REPORTED THAT THE 36 MM LINER IMPACTOR TIP WAS BROKEN INTO TWO PIECES AND NEEDS TO BE REPLACED. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY OR ADVERSE EVENT WAS EXPERIENCES. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357273 ↗MalfunctionMar 6, 2025Break; Break
IT WAS REPORTED THAT THE LINER IMPACTOR TIP BROKE DURING IMPACTING. SURGERY WASN'T DELAYED DUE TO THE REPORTED EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21539606 ↗MalfunctionOct 7, 2024Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE AT BASE OF INSERTION PART. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Insufficient Information
MAUDE report 20385670 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE PINNACLE LINER IMPACTOR BROKE INTO TWO PIECES WHEN IMPACTING IMPLANT INTO PATIENT. ALL PIECES REMOVED. NO DELAY IN SURGERY NO HARM TO PT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484485 ↗MalfunctionDec 29, 2023Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18416512 ↗MalfunctionNov 9, 2023Break; Break
IT WAS REPORTED THAT THE SURGEON WAS INSERTING AN ALTRX LINER, AND THE ORANGE IMPACTOR TIP BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED AND MATCHED TOGETHER TO MAKE SURE THAT NO SMALLER PIECES WERE GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18103811 ↗MalfunctionOct 13, 2023Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP 36MM FROM OPTIMUS TRAY WAS DAMAGED. THE PLASTIC IMPACTOR TIP WAS BROKEN INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17930043 ↗MalfunctionOct 12, 2023Break; Break
DEFECTIVE DEVICE: LINER IMPACTOR HEAD (THE OLD VERSION) - THE PLASTIC STEM OF THE HEAD BROKE. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919649 ↗MalfunctionJul 25, 2023Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP BROKE INTO TWO PIECES. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17390080 ↗MalfunctionMay 12, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT TWO DIFFERENT OFFSET IMPACTORS BREAK DURING A TOTAL HIP. ON ONE HANDLE THE HANDLE ITSELF COMPLETELY BROKE. ON THE OTHER ONE THE THREADED END PIECE BECAME STUCK AND DISASSOCIATED FROM THE POSITIONING ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16919570 ↗MalfunctionMar 28, 2023Break; Break
IT WAS REPORTED THE OPTIMUS IMPACTOR TIP IS BROKEN WITH SMALL PART BROKEN OFF INSIDE THE IMPACTOR HANDLE ON OPENING THE STERILE TRAY. PASSED OFF BEFORE CASE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632778 ↗MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP IS CRACKED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16488068 ↗MalfunctionJan 6, 2023Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP IS BROKEN INTO TWO PIECES. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16114199 ↗MalfunctionDec 15, 2022Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP BROKE WHILE IMPACTING THE LINER. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15993098 ↗MalfunctionNov 28, 2022Break; Break
OPTIMUS LINER INSERTER TIP (SIZE 36- ORANGE) FRACTURES UPON IMPACTION OF LINER. THE ORANGE TIP SNAPPED WHEN BEING IMPACTED BY A MALLET. THERE DID NOT SEEM TO BE UNNECESSARY FORCE APPLIED. ALL PIECES REMOVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868487 ↗MalfunctionNov 1, 2022Break; Break
THE INSERTION END OF THE 36MM LINER IMPACTOR TIP SNAPPED OFF WHILE IMPACTING A 36MM ACETABULAR LINER. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15708060 ↗MalfunctionOct 12, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
STAFF HAVE INDICATED ALL ITEMS REQUIRE REPLACEMENT DUE TO WEAR AND TEAR OVER TIME. THE FEMORAL HEAD TRIALS ARE WORN AND SCRATCHED. THE FEMORAL HEAD IMPACTOR TIP IS ALSO VERY WORN AWAY FROM SEVERAL USES. THE IMPACTOR TIPS ARE CROSS THREADED AND NO LONGER THREAD ONTO THE WHITE HANDLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591074 ↗MalfunctionOct 4, 2022Break; Break
IT WAS REPORTED THAT THE STEM OF IMPACTOR BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536920 ↗MalfunctionAug 22, 2022Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP WAS BROKEN INTO 2 PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15265519 ↗MalfunctionAug 19, 2022Break; Break
IT WAS REPORTED THAT THE MI IMPACTOR TIP IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258697 ↗MalfunctionJul 20, 2022Break; Break
IT WAS REPORTED THAT THE 36MM IMPACTOR TIP BROKE WHILE IMPACTING THE LINER. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO LOOSENING AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064532 ↗MalfunctionMay 7, 2022Break; Break
IT WAS REPORTED THAT WHILE INSERTING AN ALTRX LINER, AND THE IMPACTOR TIP BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED AND MATCHED TOGETHER TO MAKE SURE THAT NO SMALLER PIECES WERE CREATED. THE BROKEN PIECES WERE ASKED TO BE WASHED SO WE COULD RETURN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316880 ↗MalfunctionApr 19, 2022Break; Break
IT WAS REPORTED THAT 36MM ACETABULAR LINER IMPACTOR TIP BROKE WHILE IMPACTING THE LINER INTO THE SHELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142574 ↗MalfunctionMar 14, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP WAS BROKEN. OPERATION COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13757841 ↗
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 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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