Restoration S-2652-1117Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327019483), received between Mar 22, 2023 and Mar 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K944836); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryMar 22, 2023Degraded; Degraded

  IT WAS REPORTED THAT THERE WAS APPARENT TRUNNIONOSIS DISCOVERED AFTER REVISION. IT WAS FURTHER REPORTED THAT "PATIENT REPORTED PAIN IN GROIN/ BUTTOCKS AREA. SURGEON REVISED ACETABULUM AND NOTICED WHAT LOOKED TO BE TRUNNIONOSIS ON STEM AND HEAD. DEEP GROVE OF ARTICULATING SURFACE OF LINER WAS NOTICED AND WONDERED WHERE THAT COULD HAVE COME FROM. DISCOLOURATION (YELLOW TINGE) OF LINER IS A CONCERN AS WELL. NO INFECTION WAS PRESENT JUST A LOT OF INFLAMMATION."

  Patient problems: Inflammation; Pain

  MAUDE report 16589078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K944836. One submission often covers many models, so check the product and lot details in each record.

• Z-0467-03 · Dec 2, 2002 · Terminated
  Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.