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Restoration 504-02-56D-RRecalls & reported problems

Howmedica Osteonics Corp. · Anatomic Hemispherical Shell · 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 07613327012347), received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Injury1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJun 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    AN EXPLANTATION OPERATION WAS PERFORMED BECAUSE THE INFECTION WAS SUSPECTED.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 10142182 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

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Sources and updates

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