EMPHASYS 4814-00-050Recalls & reported problems
Depuy (Ireland) · EMPHASYS LINER IMPACTOR TIP ADAPTOR · Class 1
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy EMPHASYS liner tip adaptor is a small threaded attachment used to hold an implant in place during hip replacement surgery. The 36 reports mostly describe instruments that would not unscrew, adaptors that were cross-threaded onto the handle, and tips that were worn out or broken; several mention handling and reprocessing issues where the tip could not be removed and had to be processed as one piece. No deaths or injuries were reported, and 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295522560), received between Apr 17, 2024 and Aug 13, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (23 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
- Device-Device Incompatibility23
- Material Deformation13
- Break4
- Naturally Worn1
- No Apparent Adverse Event1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information9
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Material Deformation
It was reported that during a Total Hip Replacement surgical procedure it was observed that the instrument was cross threaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235386 ↗MalfunctionJul 8, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752193 ↗MalfunctionJul 8, 2026Material Deformation
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 25752181 ↗MalfunctionJul 8, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752153 ↗MalfunctionJul 8, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751930 ↗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 25164190 ↗MalfunctionMay 13, 2026Device-Device Incompatibility
IT WAS REPORTED THE IMPACTOR TIP AND TIP EXTENSION WON'T UNTHREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163825 ↗MalfunctionApr 11, 2026Material Deformation
IT WAS REPORTED THAT UPON INSPECTION AFTER THE CASE, IT WAS DETERMINED THAT THE EMPHASYS CUP IMPACTOR TIP PLASTIC AND METAL SLEEVE WERE CROSSED THREADED AND DAMAGED. BOTH PARTS ARE NOT USABLE. NO DELAY DURING THE CASE WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846001 ↗MalfunctionApr 2, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE CROSS THREADING OBSERVED ON BOTH MALE ENDS OF THE 2 THREADED INSTRUMENTS. SHEATH ON GRATER INNER WILL NOT LET COLLAR SETTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766442 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE INTO (B)(4) PIECES WHILE IMPACTING THE LINER. ALL PIECES WERE RETRIEVED WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716478 ↗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 24634089 ↗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 24603704 ↗MalfunctionMar 5, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TAPER SPACER HAS BECOME STRIPPED AND NO LONGER THREADS ONTO KINCISE ATTACHMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523689 ↗MalfunctionMar 5, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TAPER SPACER HAS BECOME STRIPPED AND NO LONGER THREADS ONTO KINCISE ATTACHMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523687 ↗MalfunctionMar 3, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICES WOULD NOT SEPARATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498238 ↗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 24288432 ↗MalfunctionDec 19, 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 23849830 ↗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 23788659 ↗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 23772093 ↗MalfunctionDec 5, 2025Device-Device Incompatibility; Device-Device Incompatibility
36MM LINER IMPACTOR TIP AND LINER IMPACTOR ADAPTOR IN A LOAN SET WERE UNABLE TO BE UNSCREWED FROM EACHOTHER BY STERILISING TECHNICIANS WHEN DISMANTLING FOLLOWING A CASE FOR CLEANING. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO, 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, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OFNONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23726608 ↗MalfunctionNov 4, 2025Break; Break
THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT THE EMPHASYS CUP IMPACTOR, AND THE EMPHASYS 36MM TIP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465516 ↗MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT 36 IMPACTOR WAS STUCK ON THE ADAPTOR FOR THE EMPHASIS CURVED HANDLE. COULD NOT GET OFF DURING CASE TO SWITCH TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23463538 ↗MalfunctionOct 31, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IMPACTOR WAS STUCK ON THE ADAPTER FOR THE EMPHASIS CURVED HANDLE. IT COULDN'T BE TWISTED OFF DURING THE CASE DESPITE HAVING TRIED MULTIPLE WAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437748 ↗MalfunctionSep 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
PATIENT UNDERWENT HIP SURGERY ON (B)(6), 2025. USING EMPHASYS INSTRUMENTS, THE LINER IMPACTOR ADAPTOR CROSS THREADED AS IT WAS ATTACHED TO THE IMPACTOR. THE RESULT WAS THAT THE ADAPTOR BECAME VERY TIGHT ON THE IMPACTOR HANDLE. ADDITIONALLY, THE LINER IMPACTOR HEAD SIZE 36 BECAME VERY TIGHT ON THE ADAPTOR. THE TWO HAD TO BE SEPARATED USING GRIPS AND THIS PROCESS DAMAGED THE ADAPTOR SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23137262 ↗MalfunctionSep 19, 2025Break; Device-Device Incompatibility; Scratched Material; Break; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE 36 LINER HEAD IS STUCK ON METAL ADAPTOR PIECE AND IT IS SCRATCHED AND CHIPPED TOO MUCH WHILE TRYING TO DISASSEMBLE THE ITEM. NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100986 ↗
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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