EMPHASYS 4814-32-050Recalls & reported problems
Depuy (Ireland) · EMPHASYS LINER IMPACTOR TIP 32mm · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295509677), received between Sep 5, 2024 and Apr 11, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Crack3
- Device-Device Incompatibility2
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT THE 36 LINER IMPACTOR TIP WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851947 ↗MalfunctionMar 18, 2026Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE DAY BEFORE THE SURGERY, DURING THE PRODUCT DEMONSTRATION BY THE SALES REP, THE SCREWS ON THE PRODUCTS IN QUESTION WERE SO TIGHT THAT THEY COULD NOT BE TURNED AND WERE DIFFICULT TO BE DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630439 ↗MalfunctionFeb 8, 2026Device-Device Incompatibility
EMPHASYS 32 MM LINER IMPACTOR TIP AND EMPHASYS LINER IMPACTOR TIP ADAPTOR CANNOT BE TAKEN APART. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THE DATE OF EVENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288433 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT THE EMPHASYS 32 LINER IMPACTOR TIP BROKE WHEN BEING USED TO IMPACT THE LINER INTO THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292430 ↗MalfunctionMay 15, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THERE WERE BROKEN EMPHASYS IMPACTORS. SURGEON AND HOSPITAL WANTED THEM REPLACED AS THERE WERE CRACKS IN THEM. PLEASE SEND REPLACEMENTS.
Patient problems: Insufficient Information
MAUDE report 22027721 ↗MalfunctionMay 15, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THERE WERE BROKEN EMPHASYS IMPACTORS. SURGEON AND HOSPITAL WANTED THEM REPLACED AS THERE WERE CRACKS IN THEM. PLEASE SEND REPLACEMENTS.
Patient problems: Insufficient Information
MAUDE report 22027676 ↗MalfunctionMay 15, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THERE WERE BROKEN EMPHASIS IMPACTORS. SURGEON AND HOSPITAL WANTED THEM REPLACED AS THERE WERE CRACKS IN THEM. PLEASE SEND REPLACEMENTS.
Patient problems: Insufficient Information
MAUDE report 22027618 ↗MalfunctionNov 21, 2024Material Deformation; Material Deformation
IT WAS REPORTED ON (B)(6) 2024 THAT 32 TIP FOR CROSS THREADED AND 1 BROACH DON¿T LATCH ON BROACH HANDLE WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748381 ↗MalfunctionSep 5, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT 32 IMPACTOR HAS BAD THREADS. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20143898 ↗
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- 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.