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Restoration 1235-2-521Recalls & reported problems

Howmedica Osteonics Corp. · ADM- Cup w/HA · Class 2 · Implant

All models of Restoration (86)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 04546540638748), received between Jun 8, 2023 and Jun 8, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 18, 2026.

Most reported problems

Device problems

  • Degraded1

Patient problems

  • Foreign Body Reaction1

Recent adverse event reports

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

  • InjuryJun 8, 2023Degraded; Degraded

    AS REPORTED: "DR. PERFORMED A RIGHT HIP REV DUE TO ALTR." A HEAD, LINER AND SHELL WERE REVISED.

    Patient problems: Foreign Body Reaction

    MAUDE report 17088703 ↗

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

All Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices →

Sources and updates

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