Masterloc Femoral Stems 01.39.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030885556), received between Dec 6, 2017 and Dec 5, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 5 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18267224 ↗
• InjuryMar 10, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM 6 YEARS AND 2 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE STEM, HEAD, LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16521454 ↗
• InjuryDec 6, 2017Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THAT THE STEM HAD SLIGHTLY SUBSIDED. THE SURGEON SWAPPED THE HEAD AND IMPLANTED AN OPTION SLEEVE WITH ANOTHER HEAD. THE STEM WAS NOT REVISED AS IT IS NOW STABLE.

  Patient problems: Joint Disorder

  MAUDE report 7086820 ↗