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ELITE PLUS 9653-28-040Recalls & reported problems

Depuy (Ireland) · ELITE PLUS CUP OGEE - CEMENTED LPW 28mmID 40mmOD · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295318811), received between Sep 28, 2018 and Sep 28, 2018 — classified as 1 malfunction.

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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    WHEN OPENING THE PACKAGE THE PRODUCT SEEMED OXIDATED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7919165 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.