Masterloc Femoral Stems 01.39.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030885617), received between May 11, 2021 and Nov 15, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionNov 15, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DURING THE PRIMARY HIP SURGERY, WHEN THE AGENT OPENED UP THE STEM IMPLANT, IT WAS OBSERVED THAT THE IMPLANT HAD BROKEN THROUGH THE STERILE PACKAGING AND THE CAUSE IS UNKNOWN. THE ISSUE WAS NOTED WHEN THE FEMORAL BONE WAS ALREADY PREPARED. THE SURGEON DECIDED TO RE-STERILIZE IT BECAUSE NO BACK-UP WAS AVAILABLE AND THEY COULD NOT GO DOWN OR UP IN SIZE. THE PIECE WAS RE-STERILIZED WITH STEAM STERILIZATION. THE ISSUE CAUSED 45-MINUTE DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY; ADDITIONAL ANESTHESIA WAS ADMINISTERED. ONLY ONE BLOCKER WAS INSIDE THE PACKAGING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18139035 ↗
• InjuryMay 11, 2021Fracture

  INTRAOPERATIVE SPIRAL FEMUR BONE FRACTURE OCCURRED. THE SURGEON CABLED THE FRACTURE AND COMPLETED SUCCESSFULLY THE SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11804379 ↗