ELITE PLUS 9653-28-043Recalls & reported problems
Depuy (Ireland) · ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 43mmOD · 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 10603295318828), received between Apr 16, 2021 and Apr 4, 2023 — 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.
Most reported problems
Device problems
- Loss of or Failure to Bond1
- Migration1
Patient problems
- Insufficient Information1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2023Migration; Migration
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE CUP AND THE IMPLANT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE THE IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Tissue Injury
MAUDE report 16672812 ↗InjuryApr 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS DECIDED THAT ALL THE IMPLANTS WOULD BE REMOVED IN THE REVISION SURGERY DUE TO INFECTION ON (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 11680976 ↗
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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