P.F.C. 85-3962Recalls & reported problems
Depuy (Ireland) · P.F.C. FEMORAL HEAD IMPACTOR · Class 1
Data updated Oct 18, 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 10603295207795), received between Jul 23, 2018 and Jun 9, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (4 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 18, 2026.
Most reported problems
Device problems
- Scratched Material4
- Crack1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE IMPACTOR SURFACE IS SCRATCHED AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11967378 ↗MalfunctionJan 22, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT IMPACTION SURFACE WAS SCRATCHED BADLY. NO SURGICAL DELAY NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11214637 ↗MalfunctionNov 16, 2020Scratched Material; Scratched Material
IT WAS REPORTED THAT THE IMPACTION SURFACE IS SCRATCHED BADLY AND NEEDS REPLACING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10845568 ↗MalfunctionOct 29, 2020Scratched Material; Scratched Material
IT WAS REPORTED THAT THE HEAD IMPACTOR WAS SCRATCHED ON THE IMPACTION SURFACE, AND NEEDED REPLACING. NO SURGICAL DELAY NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10754632 ↗MalfunctionJul 23, 2018Crack; Crack
IT WAS REPORTED THAT THE HEAD IMPACTOR CAME BACK CRACKED FROM STERILE PROCESSING DEPARTMENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7709770 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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