ELITE PLUS 9652-28-043Recalls & reported problems
Depuy (Ireland) · ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 43mmOD · Class 2 · Implant
- 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 10603295318637), received between Apr 3, 2024 and Apr 3, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE (15 YEARS AGO), THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA WITH THE CUP AND STEM IN QUESTION. ON AN UNKNOWN DATE, INFECTION WAS CONFIRMED. THEREFORE, ON (B)(6) 2024, THE RIGHT SIDE OF THE CUP AND STEM IN QUESTION WERE REMOVED. BECAUSE THE PATIENT WAS ELDERLY, AND THE SURGERY WAS A GIRDLESTONE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 19034582 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.