Restoration S-2651-0812Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327019315), received between Jan 22, 2019 and Jan 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical 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.

• InjuryJan 22, 2019Mechanical Problem; Mechanical Problem

  "ON (B)(6) 2012 SHE NOTED "PAIN FOR FIVE MONTHS ... TOLD HEMATOMA RETURNED". MRI SHOWED "POSSIBLE METALLOSIS". [...] DURING THE LEFT HIP REVISION SURGERY, "AT SURGERY AN IMPINGEMENT OF THE TITANIUM NECK ON THE ACETABULAR RIM WITH METALLOSIS IN THE JOINT AND ANTERIOR CYST "LIKELY DUE TO METALLOSIS" WAS NOTED." UPDATE 17-JAN-2019: MEDICAL REVIEW CLARIFIED THAT TRITANIUM NECK IMPINGED ON THE METAL RIM OF THE CERAMIC INSERT.

  Patient problems: Hematoma; Inflammation; Injury; Pain; Reaction

  MAUDE report 8269044 ↗

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.