ELITE PLUS 9653-26-047Recalls & reported problems
Depuy (Ireland) · ELITE PLUS CUP OGEE - CEMENTED LPW 26mmID 47mmOD · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295318781), received between Dec 14, 2022 and Jul 30, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
- Migration1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT (B)(6) 2005, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA FOR OA ON THE RIGHT HIP JOINT WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, THE SIGNS OF LOOSENING OF THE ACETABULAR IMPLANTS WERE CONFIRMED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2025 . NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22668209 ↗InjuryDec 14, 2022Migration; Migration
THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE EVENT WHICH OCCURRED IN THE REVISION SURGERY. THIS PC REPORTS ABOUT THE MIGRATION WHICH OCCURRED AFTER THE FIRST SURGERY. IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE MIGRATION OCCURRED ON THE IMPLANT ON THE CUP SIDE. THE REVISION SURGERY WAS PERFORMED ON (B)(6)2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15983647 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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