ELITE 9625-67-000Recalls & reported problems
Depuy (Ireland) · ELITE FEMORAL HEAD +0 9/0 TAPER Diameter 22.225mm · Class 2 · Implant
All models of ELITE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295243144), received between Mar 23, 2020 and Mar 23, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRIMARY SURGERY WAS PERFORMED IN 2002 (THE DATE WAS UNKNOWN) VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY (THE DATE WAS UNKNOWN) WAS PERFORMED BY REPLACING THE C-STEM (P/N: UNKNOWN) AND THE CUP (P/N: UNKNOWN) DUE TO THE SUBLUXATION WHICH THE PATIENT HAD 3 MONTHS BEFORE THE REVISION SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY, AND IT WAS UNKNOWN WHETHER THERE WAS SURGICAL DELAY OR NOT. THE CONDITION AFTER SURGERY WAS GOOD. THE SURGEON FOUND THAT THERE WAS SOMETHING LIKE A CORROSION FROM THE MIDDLE POINT TO DISTAL PART OF THE EXPLANTED STEM. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Code Available
MAUDE report 9867986 ↗
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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