EMPHASYS 4814-36-050Recalls & reported problems
Depuy (Ireland) · EMPHASYS LINER IMPACTOR TIP 36mm · Class 1
Quick summary
This DePuy Emphasys 36mm liner impactor tip is used to seat hip cup liners during surgery. The 69 reports mostly describe the tip snapping or cracking, sometimes into two pieces, and sometimes becoming brittle or wearing out; a few mention it not fitting well with other instruments. 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
- 68
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10603295509684), received between Sep 5, 2023 and Sep 29, 2026 — classified as 68 malfunctions.
The most frequently reported specific device problem is “Break” (40 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
- Break40
- Device-Device Incompatibility16
- Crack11
- Material Deformation5
- No Apparent Adverse Event2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- Insufficient Information12
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation
It was reported that when the tech was putting the size 36 head impactor tip onto the adapter and impactor handle, the internal threads of the impactor tip became stripped. There was no issues or delays were caused.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931279 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790897 ↗MalfunctionJul 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848617 ↗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 25752233 ↗MalfunctionJul 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752227 ↗MalfunctionJul 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752140 ↗MalfunctionJul 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752008 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE TWO THINGS HAPPENED IN THIS CASE. WHILE THE SURGEON WAS IMPACTING THE POLY INTO THE ACETABULAR CUP THE IMPACTOR TIP BROKE. NO DELAY IN CASE AND NO ISSUES TO THE PATIENT. ALL PIECES WERE ACCOUNTED FOR. THE SECOND THING THAT HAPPENED WAS THERE WAS A SHARP EDGE ON THE BROACH HANDLE THAT TORE THE SURGEONS GLOVE. NO ISSUES WITH EITHER THE SURGEON OR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670520 ↗MalfunctionJun 10, 2026Crack; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND STRIPPED AND CRACKED IN THE STERILE PROCESSING DEPARTMENT (SPD).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25455769 ↗MalfunctionMay 13, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTOR TIP AND THE IMPACTOR TIP EXTENSION WON'T UNTHREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164080 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED THAT THE 36 LINER IMPACTOR TIP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153467 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED THAT THE SURGEON WAS UTILIZING THE 36MM EMPHASYS POLY INSERTER AND THE PLASTIC TIP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148573 ↗MalfunctionMay 5, 2026Break
IT WAS REPORTED THAT THE T- HANDLE WAS BROKEN. THE PLASTIC HAND PIECE CRACKED AND UNABLE TO BE USED. THE EVENT DID NOT HAPPEN DURING SURGERY. IT WAS REPORTED THAT THERE WERE OTHER DEVICES THAT ALSO NEEDED REPLACEMENT. THE T-HANDLE AND ANTERIOR INSERTER FROM THE CORAIL TRAYS, ALONG WITH EMPHASYS 36 LINER IMPACTOR TIP. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086025 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT THE 36 LINER IMPACTOR TIP BROKE AFTER IMPACTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931495 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865937 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THAT IMPACTOR TIP BROKE UPON IMPACTING THE LINER. ALL THE PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865412 ↗MalfunctionApr 13, 2026Crack
IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24864953 ↗MalfunctionApr 13, 2026Crack
IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24864841 ↗MalfunctionMar 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE 36 LINER IMPACTOR AND EMPHASIS ADAPTOR WERE FUSED TOGETHER. THERE WAS NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603690 ↗MalfunctionMar 3, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICES WOULD NOT SEPARATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498244 ↗MalfunctionFeb 25, 2026Material Deformation
IT WAS REPORTED THAT THE THREADING WAS STRIPPED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443761 ↗MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, DURING THE SECOND MALLET SWING, THE 36 IMPACTOR EXPLODED INSIDE OF THE PATIENT. IT WAS REPORTED THAT A THOROUGH EXPLORATION WAS PERFORMED AND THE SURGEON BELIEVES THAT ALL OF THE FRAGMENTS WERE RETRIEVED. IT WAS REPORTED THAT THERE WAS A DELAY DUE TO RETRIEVING ALL OF THE FRAGMENTS. IT WAS REPORTED THAT THE LINER IMPACTOR WAS ASSEMBLED FULLY ON TO THE ADAPTER. LOT NUMBER UNKNOWN. TOO MANY FRAGMENTS. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278909 ↗MalfunctionDec 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT LINER IMPACTOR TIP STUCK ON ADAPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861225 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT THE EMPHASYS 36MM HEAD IMPACTOR BROKE INTO 2 PIECES WHEN INSERTING THE LINER. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848522 ↗MalfunctionDec 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772038 ↗
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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.