NA 71362807Recalls & reported problems
Smith & Nephew, Inc. · FEMORAL HEAD REPLACEMENT PLASTIC TIP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556025871), received between May 2, 2019 and Oct 27, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break3
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THA REVISION SURGERY, THE SURGEON USED THE IMPACTOR TO HIT OFF THE FEMORAL HEAD, AND ONE (1) FEMORAL HEAD REPLACEMENT PLASTIC TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED BY HAND. ALL PARTS RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389358 ↗MalfunctionAug 15, 2023Break; Break
IT WAS REPORTED THAT, DURING THR SURGERY, A FM HEAD REPL PLAS TIP WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17553338 ↗MalfunctionSep 27, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE TIP OF ONE (1) FEMORAL HEAD IMPACTOR BROKE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491773 ↗MalfunctionNov 13, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY A PART OF THE IMPACTOR TIP BROKE OFF DURING IMPACTION OF THE FEMORAL HEAD. NO PIECES FELL INSIDE THE PATIENT. NO INJURY REPORTED, A DELAY BELOW 30 MIN WAS REPORTED. A S&N BACKUP DEVICE WAS USED TO FINISH THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9318682 ↗MalfunctionMay 2, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE IMPACTOR TIP BROKE DURING FINAL IMPACTION OF THE IMPLANT. HAD BACKUP, DELAY OF LESS THAN 30 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573925 ↗
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- 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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