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Restoration 6276-7-018Recalls & reported problems

Howmedica Osteonics Corp. · Modular Hip System · Class 2 · Implant

All models of Restoration (86)

Data updated Oct 16, 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 04546540643766), received between Sep 24, 2019 and Sep 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16, 2026.

Most reported problems

Device problems

  • Osseointegration Problem1

Patient problems

  • Inadequate Osseointegration1
  • Injury1
  • Pain1

Recent adverse event reports

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

  • InjurySep 24, 2019Osseointegration Problem; Osseointegration Problem

    PATIENT PRESENTED WITH LYSIS. LOOSE AT THE BODY STEM INTERFACE. REVISION OF CONE CONICAL RESTORATION, MODULAR STEM. LEFT THA. UPDATE: "THE REASON FOR REVISION WAS PT PAIN AND LYSIS ON SCANS. THE SURGEON HYPOTHESISED THAT IT MAY HAVE BEEN A LOOSE STEM/ BODY INTERFACE."

    Patient problems: Inadequate Osseointegration; Injury; Pain

    MAUDE report 9111369 ↗

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

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

Sources and updates

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