EMPHASYS 2999-66-959Recalls & reported problems
Depuy Orthopaedics, Inc. · EMPHASYS MAKE TO ORDER CUP IMPACTOR 13 INCH · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295549017), received between Dec 11, 2024 and Apr 15, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 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
- Material Deformation3
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Material Deformation
IT WAS REPORTED THAT THE EMPHASYS CUP HANDLE WAS STRIPPED AND WOULD NO LONGER ACCEPT THE IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886954 ↗MalfunctionJun 17, 2025Material Deformation; Material Deformation
DURING MDRD INSPECTION, THE THREADS OF THE CUP IMPACTOR WERE DEEMED DAMAGED AND NO LONGER UNIFORM. THE DEVICE IS NOT SUITABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22234988 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING MDRD INSPECTION, THE THREADS OF THE INSERTER WAS FOUND TO BE DAMAGED AND NO LONGER SUITABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THE THREADS WHICH ARE USED TO CONNECT THE IMPACTOR TO THE CUP IT IS INTENDED TO IMPACT ARE DAMAGED AND WILL NO LONGER THREAD INTO THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059405 ↗MalfunctionDec 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN ATTEMPTING TO THREAD THE CUP IMPACTOR ONTO THE HANDLE, THE THREADS WOULD NOT ENGAGE WITH EACH OTHER. ALTERNATE SET WAS OPENED TO PROCEED WITH THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903878 ↗
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.