Masterloc Femoral Stems 01.39.207Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030885679), received between Jul 13, 2018 and Mar 7, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21548760 ↗
• InjuryJul 10, 2024Osseointegration Problem; Osseointegration Problem

  ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT COMPLAINED OF THIGH PAIN. THERE WAS NO SIGN OF INFECTION BUT THE X-RAYS SHOWED SIGNS OF STEM LOOSENING. DURING THE REVISION, THE STEM WAS PERFECTLY FIXED, SO THE SURGEON PLACED A SLEEVE AND REVISED THE HEAD.

  Patient problems: Implant Pain

  MAUDE report 19711156 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE FIRST RECOVERY DAY, A FEMUR FRACTURE WAS DETECTED. AT 1 DAY FROM THR THE SURGEON REVISED THE STEM AND HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 16417235 ↗
• InjuryMay 13, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. AT 3 YEARS AND 1 MONTH FROM PRIMARY THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14397933 ↗
• InjuryAug 2, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS A FRACTURE OF THE FEMUR (REASON UNKNOWN). THE SURGEON REVISED THE STEM, HEAD, AND LINER 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 12258537 ↗
• InjuryJun 19, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 11 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8711047 ↗
• InjuryDec 14, 2018Patient-Device Incompatibility

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO THE STEM SUBSIDING, 8 MONTHS AND A HALF AFTER PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8164770 ↗
• InjuryJul 31, 2018Crack

  DURING SURGERY THE SURGEON IMPLANTED THE REAL STEM AND CRACKED THE CALCAR. THE SURGEON FELT THE IMPLANT DID NOT MATCH THE BROACH AND DUE TO THE COMPROMISED BONE AND WIRE TO FIX THE FRACTURE HE DECIDED TO GO WITH A CEMENTED SIZE 4 STANDARD STEM. THE CEMENTLESS STEM WAS DISCARDED. NO DELAY.

  Patient problems: Hip Fracture

  MAUDE report 7734721 ↗
• InjuryJul 13, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A STEM SUBSIDENCE. THE SURGEON REPLACED SUCCESSFULLY THE STEM AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7685637 ↗