Masterloc Femoral Stems 01.39.209Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030885693), received between Apr 18, 2018 and Jul 3, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY, THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 22394420 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY HIP SURGERY ON (B)(6) 2024, IT WAS OBSERVED THAT THE PATIENT HAD SUSTAINED AN INTRA-OP FRACTURE. THE SURGEON CABLED THE FRACTURE AROUND THE PROXIMAL PART AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE SURGEON NOTICED THAT THE FRACTURE WAS BELOW THE PROXIMAL PART. SINCE THE SURGEON DID NOT CABLE DISTALLY DURING THE PRIMARY, HE DECIDED TO REVISE THE PATIENT. THE STEM AND HEAD WERE SUBSTITUTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18657246 ↗
• InjuryDec 17, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT'S FEMUR FRACTURED BELOW THE LOWER DISTAL TIP OF THE STEM. IT IS UNKNOWN HOW THIS OCCURRED. TWO WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD WEAK BONE. ON THE ORIGINAL PRIMARY SURGERY WE UTILIZED THE STRAIGHT STEM IMPACTOR ALONG WITH THE STANDARD BROACHES WITH THE DIRECT ANTERIOR BROACH HANDLES. WE ARE NOT SURE WHEN THE FRACTURE HAPPENED. IT IS A POSSIBILITY THAT THE FRACTURE OCCURRED DURING THE PRIMARY HIP REPLACEMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 13025505 ↗
• InjuryJul 4, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD POOR BONE QUALITY AND FRACTURED HER FEMUR 4 MONTHS AFTER PRIMARY. THERE WAS NO REPORT OF TRAUMA. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7662368 ↗
• InjuryApr 18, 2018Device Slipped

  ABOUT 1 YEAR AND A HALF AFTER PRIMARY THE SURGEON REVISED THE JOINT FOR A HIP INFECTION. THE INFECTION CAUSED A STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 7439186 ↗