NA 2001-66-000Recalls & reported problems
Depuy (Ireland) · FEMORAL HD IMPACTOR REPL TIP · Class 1
Quick summary
This DePuy femoral head impactor tip is a surgical tool used to seat the ball of a hip implant. Many of its 88 reports describe the tip wearing, scratching, denting, or breaking, sometimes into two pieces. The reports include no deaths and no injuries. Reports rose from 3 in the prior 12 months to 11 in the last 12 months. 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
- 90
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10603295080138), received between Sep 20, 2017 and Sep 28, 2026 — classified as 90 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (46 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
- Naturally Worn46
- Break23
- Material Twisted/Bent21
- Scratched Material21
- Material Deformation17
- Device-Device Incompatibility5
- Crack4
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Consequences Or Impact To Patient21
- No Code Available5
- No Information1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Device-Device Incompatibility; Material Deformation
It was reported that the poly tip #200166000 of the head impactor from the sets was cross-threaded and did not screw onto the handle. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917903 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564658 ↗MalfunctionJun 5, 2026Break; Crack
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DEVICE CRACKED AND BROKE INTO 2 PIECES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409835 ↗MalfunctionMay 21, 2026Material Deformation; Scratched Material
IT WAS REPORTED THAT THE IMPACTOR TIPS DENTED AND SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238231 ↗MalfunctionMay 21, 2026Material Deformation; Scratched Material
IT WAS REPORTED THAT THE IMPACTOR TIPS DENTED AND SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238230 ↗MalfunctionMay 21, 2026Material Deformation; Scratched Material
IT WAS REPORTED THAT THE IMPACTOR TIPS DENTED AND SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238229 ↗MalfunctionMay 21, 2026Material Deformation; Scratched Material
IT WAS REPORTED THAT THE IMPACTOR TIPS DENTED AND SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238228 ↗MalfunctionApr 21, 2026Material Deformation; Scratched Material
IT WAS REPORTED THAT THE FEMORAL HEAD IMPACTOR TIP WAS DENTED, SCRATCHED, AND DEFORMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942483 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT THE HEAD OF THE IMPACTOR TIP, BROKE INTO 2 PIECES, ALL PIECES RECOVERED. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897115 ↗MalfunctionFeb 20, 2026Break
IT WAS REPORTED THAT THE REPL TIP FEMORAL HD IMPACTOR AND MODULAR CALCAR PLANER LRG WERE DAMAGED/BROKEN FOLLOWING SURGERY AND/OR DURING THE WASH. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401784 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT THE HEAD PUSHER TIPS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936763 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT THE HEAD PUSHER TIPS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936762 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT THE HEAD PUSHER TIPS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936761 ↗MalfunctionJul 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOSS ADAPTOR CROSS THREADED STEMS NO LONGER THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398593 ↗MalfunctionJul 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOSS ADAPTOR CROSS THREADED STEMS NO LONGER THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398584 ↗MalfunctionJul 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOSS ADAPTOR CROSS THREADED STEMS NO LONGER THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398579 ↗MalfunctionOct 15, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE INTERNAL THREADS OF THE DEVICE WERE DAMAGED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451447 ↗MalfunctionMar 13, 2024Break; Break
IT WAS REPORTED THAT THE SALES REP WAS INFORMED THAT THE HEAD IMPACTOR BROKE DURING CLEANING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18894366 ↗MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT BOTH INSERTER AND HEAD IMPACTORS ARE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156106 ↗MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT BOTH INSERTER AND HEAD IMPACTORS ARE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156100 ↗MalfunctionJun 20, 2023Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE INCIDENT DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17165008 ↗MalfunctionJun 1, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE ITEM WAS NOT FIT FOR PATIENT USE DUE TO WEAR AND TEAR. THE WEAR AND TEAR IS GENERAL WEAR AND TEAR WE SEE ON THIS SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17041591 ↗MalfunctionMay 31, 2023Naturally Worn; Naturally Worn
DEVICE WAS REPORTED FOR GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032417 ↗MalfunctionApr 4, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT DEVICE IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16676265 ↗MalfunctionApr 4, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT TRIAL HEAD IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674933 ↗
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.