Masterloc Femoral Stems 01.39.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030885570), received between Jan 19, 2018 and Nov 6, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 3 WEEKS FROM THE PRIMARY, REVISION SURGERY DUE TO THREE-PART FEMORAL BONE FRACTURES. PATIENT OVERWEIGHT. COMPETITOR'S DEVICE IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20618490 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem

  SPIRAL FEMUR BONE FRACTURE HAPPENED DURING SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11804822 ↗
• InjuryJan 9, 2019Loose or Intermittent Connection; Unstable

  ON (B)(6) 2018 WE WERE INFORMED THAT A PATIENT CAME IN DUE TO INSTABILITY CAUSED BY A LOOSE STEM 2 YEARS AND 1 MONTH AFTER THE PRIMARY. ON THE NEXT DAY THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8230882 ↗
• InjuryJan 19, 2018Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN WAS DUE TO THE STEM BEING UNDERSIZED.

  Patient problems: Joint Disorder

  MAUDE report 7206134 ↗