DJO SURGICAL 400-32-400Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912076401), received between Sep 11, 2015 and Dec 11, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
Patient problems
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Joint Dislocation1
- No Information1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY, DUE TO CUP MIGRATED AND POSSIBLE FALL.
Patient problems: Fall
MAUDE report 13904714 ↗InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND BONE VOID.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 11413633 ↗InjuryApr 25, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING A DISLOCATION.
Patient problems: No Information
MAUDE report 8552271 ↗InjuryDec 28, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING. THE REVISION SURGERY WAS REQUIRED TO PLACE A MORE CONSTRAINED LINER OPTION. THE REPRESENTATIVE INDICATED HE DID NOT KNOW ANYTHING ABOUT THE FIRST SURGERY, OTHER THAN IT WAS AT THE SAME HOSPITAL AND DIFFERENT DOCTOR. HE WAS NOT ABLE TO GET A FIRST SURGERY DATE. THE IMPLANT LOT NUMBER IS NOT PULLING UP ANY HISTORY IN OUR DATABASE EITHER SO THERE IS NOTHING ON THE FIRST SURGERY.
Patient problems: No Code Available
MAUDE report 7152543 ↗InjurySep 11, 2015Device Dislodged or Dislocated
REVISION SURGERY - DISLOATION DUE TO THE STEM SUBSIDING.
Patient problems: No Code Available
MAUDE report 5071410 ↗
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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