Restoration S-2652-1218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327019506), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 injury.

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

• InjuryFeb 20, 2019Osseointegration Problem; Osseointegration Problem

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT (B)(6) 2013. PATIENT UNDERWENT THE RIGHT HIP REVISION FOR MECHANICAL LOOSENING OF FEMORAL COMPONENT ON (B)(6) 2014. ALL COMPONENTS EXCHANGED EXCEPT ACETABULAR CUP.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8353257 ↗

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.