DJO SURGICAL 400-32-004Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL 32/-4 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912076388), received between May 16, 2018 and May 26, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Corroded” (1 report).
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
- Appropriate Device Problem Term/Code Not Available1
- Corroded1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Metal Shedding Debris1
Patient problems
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pain1
- Test Result1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2021Insufficient Device Problem Information
REVISION SURGERY - UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11891452 ↗InjurySep 5, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7848205 ↗InjuryMay 16, 2018Corroded; Metal Shedding Debris
REVISION SURGERY - DUE TO THE PATIENT HAVING ELEVATED COBALT AND CHROMIUM LEVELS, GROIN PAIN, AND FOOT DROP IN LEFT LEG. THE METAL HEAD AND MODULAR NECK HAD CREVICE CORROSION.
Patient problems: Pain; Test Result
MAUDE report 7519859 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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