EMPHASYS 4814-40-050Recalls & reported problems
Depuy (Ireland) · EMPHASYS LINER IMPACTOR TIP 40mm · Class 1
Quick summary
This DePuy Emphasys 40mm liner impactor is a surgical instrument tip used to press a hip liner into place during replacement surgery. The 43 reports mostly describe the tip breaking or cracking during use, with pieces breaking off or working loose from its adaptor, and in some cases fragments left in the patient that had to be retrieved. No deaths and no injuries are 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
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295510208), received between Nov 17, 2023 and Jul 8, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Break” (32 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
- Break32
- Crack6
- Device-Device Incompatibility4
- Entrapment of Device1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Insufficient Information6
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752252 ↗MalfunctionJul 8, 2026Break
IT WAS REPORTED THAT THE ADAPTORS AND POLY IMPACTORS ARE WORN OUT. ADAPTORS X 4, 36 POLY TIP X4 AND 40 POLY TIP X4. THE ADAPTORS ARE CROSS THREADED AND THE POLY IMPACTORS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752101 ↗MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT THE ADAPTORS AND POLY IMPACTORS WERE WORN OUT. FOUR ADAPTORS, FOUR 36 POLY TIPS, AND FOUR 40 POLY TIPS WERE IDENTIFIED. THE ADAPTORS WERE CROSS-THREADED. THE POLY IMPACTORS WERE BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682122 ↗MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT THE ADAPTORS AND POLY IMPACTORS WERE WORN OUT. FOUR ADAPTORS, FOUR 36 POLY TIPS, AND FOUR 40 POLY TIPS WERE IDENTIFIED. THE ADAPTORS WERE CROSS-THREADED. THE POLY IMPACTORS WERE BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682121 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT THE 40MM MODULAR EMPHASYS IMPACTOR TIP BROKE CIRCUMFERENTIALLY IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555025 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT THE 40MM IMPACTOR TIP BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354913 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT LINER IMPACTOR TIP BROKE WHILE INSERTING LINER. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176553 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE INTO 2 PIECES WHEN SURGEON WAS IMPLANTING THE LINER. BOTH PIECES WERE IMMEDIATELY RETRIEVED AND THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866006 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE INTO PIECES WHEN THE SURGEON IMPACTED THE LINER. ALL PIECES WERE RETRIEVED AND THE SURGERY EXPERIENCED NO DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792775 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT THE LINER IMPACTOR BROKE DURING NORMAL IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752814 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT THE SURGEON WAS IMPACTING THE LINER. THE 40 IMPACTOR TIP BROKE INTO PIECES. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618921 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO THREE PIECES WHILE IMPACTING THE LINER. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500293 ↗MalfunctionFeb 3, 2026Crack
IT WAS REPORTED THAT THE IMPACTOR CRACKED DURING NORMAL IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24249459 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IMPACTOR TIP BROKE WHEN IMPACTING THE LINER. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854333 ↗MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
EMPHASYS 40 MM LINER IMPACTOR TIP AND EMPHASYS LINER IMPACTOR TIP ADAPTOR ARE STUCK TOGETHER 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788661 ↗MalfunctionNov 26, 2025Crack; Crack
IT WAS REPORTED THAT THE 40 IMPACTOR TIP WAS CRACKED WHILE INSERTING A DUAL MOBILITY LINER. IT DID NOT FULLY BREAK AND THERE WAS NO SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656612 ↗MalfunctionNov 7, 2025Break; Break
IT WAS REPORTED THAT IMPACTOR TIP BROKE WHEN LINER WAS IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495436 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE WHEN IMPACTING. ALL PIECES REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368319 ↗MalfunctionSep 19, 2025Break; Break
IT WAS REPORTED THAT THE HEAD IMPACTOR WAS BROKE APART DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096844 ↗MalfunctionSep 11, 2025Break; Break
IT WAS REPORTED THAT THE 40 IMPACTOR TIP BROKE INTO 2 PIECES WHEN IMPACTING THE LINER. BOTH PIECES WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027827 ↗MalfunctionAug 18, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE 40 IMPACTOR TIP BROKE INTO PIECES. SURGERY WAS NOT EXTENDED AND ALL PIECES WERE FOUND AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22833274 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT 40 IMPACTOR BROKE IN HALF. SURGERY TIME WAS NOT EXTENDED AND ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803848 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED THAT SURGEON BROKE THE IMPACTOR TIP WHEN HE IMPACTED THE DUAL MOBILITY LINER. IT BROKE INTO 2 PIECES AND BOTH PIECES WERE RETRIEVED. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560612 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT THE EMPHASYS 40 IMPACTOR TIP BROKE INTO 2 PIECES WHILE IMPACTING THE LINER. NO SURGICAL DELAY OCCURRED AND BOTH PIECES WERE QUICKLY RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437718 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE WHILE TRYING TO BE REMOVED FROM ADAPTER IN SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330677 ↗
Other IMPACTOR devices
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- 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.