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Restoration 1235-2-581Recalls & reported problems

Howmedica Osteonics Corp. · ADM- Cup w/HA · 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 04546540638809), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Malposition of Device1

Patient problems

  • Injury1
  • Pain1

Recent adverse event reports

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

  • InjuryOct 17, 2018Malposition of Device; Malposition of Device

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. SURGEON REPORTED THE SHELL WAS MALPOSITIONED. THE SHELL, LINER AND HEAD WERE REVISED.

    Patient problems: Injury; Pain

    MAUDE report 7975816 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices →

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