Masterloc Femoral Stems 01.39.208Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030885686), received between Sep 1, 2017 and Nov 28, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AFTER 7 YEARS AND 8 MONTHS POST-PRIMARY SURGERY DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23669505 ↗
• InjuryMar 21, 2023Malposition of Device; Malposition of Device

  AT ABOUT 5 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN UNSTABLE HIP. THERE WAS ANTEVERSION OF THE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16583376 ↗
• InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY HIP SURGERY, THE SURGEON NOTICED A FRACTURE OF THE FEMUR WHILE IMPLANTING MASTERLOC STEM. IT WAS DETERMINED THAT A REVISION STEM WAS NEEDED AND A COMPETITORS STEM WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14684585 ↗
• InjurySep 17, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN AND X-RAYS INDICATED RADIOLUCENCY'S AROUND THE STEM. THE STEM WAS LOOSE. 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12486811 ↗
• InjurySep 15, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 8 MONTHS AFTER PRIMARY SURGERY DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12473170 ↗
• InjurySep 1, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM HAS BECOME LOOSE. THE SURGEON EXPLANTED THE LINER, HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAY ARE AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6837590 ↗