Masterloc Femoral Stems 01.39.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030885587), received between Jul 4, 2017 and Jun 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Break; Break

  DURING THE PRIMARY HIP SURGERY, WHEN THE SURGEON WAS IMPLANTING THE STEM, A FEMORAL BONE FRACTURE OCCURRED. THE SURGEON CABLED THE FRACTURE AND UPSIZED THE STEM TO COMPLETE THE CASE. THERE WAS A 30-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE SAME SURGERY, THE SURGEON WANTED TO USE TWO STEM REPOSITIONERS TO EXTRACT THE STEM. THIS IS BECAUSE THE FEMORAL BONE FRACTURE OCCURRED THROUGHOUT THE IMPLANTATION OF SIZE 9 MASTERLOC STD OFFSET STEM. THE TWO REPOSITIONERS SLIP OFF THE TAPER OF THE STEM MANY TIMES, SO AN ALTERNATIVE MEDACTA EXTRACTION DEVICE WAS USED. THE SURGEON CABLED THE FRACTURE AND IMPLANTED A SIZE 10 MASTERLOC STD OFFSET STEM TO COMPLETE THE CASE. THERE WAS A 30-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14684862 ↗
• InjuryJul 4, 2017Fracture

  X-RAYS SHOWED A FRACTURE OF THE GREATER TROCHANTER. THE PATIENT WAS WALKING WITH NO PAIN. THE SURGEON IS UNSURE HOW THE PATIENT FRACTURED. THE SURGEON REVISED THE STEM AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6685269 ↗