MiniMAX Stems 01.13.104RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030803222), received between Aug 30, 2018 and Jan 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 15, 2017Class IITerminated

   Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

   Z-0196-2019 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN AFTER TWISTING THE HIP. NO PROBLEM WITH THE DEVICES. THE FEMUR FRACTURED. AT ABOUT 3 WEEKS FROM PRIMARY 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: Hip Fracture

  MAUDE report 21229329 ↗
• InjuryJan 28, 2022Fracture; Fracture

  REVISION SURGERY WAS PERFORMED DUE TO STEM NECK BREAKAGE. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. ON (B)(6) 2020 THE HEAD, LINER, AND CUP WERE REVISED DUE TO JOINT DISLOCATION. DURING THE FIRST REVISION SURGERY, THE HEAD PUT IN WAS A MERETE BIO BALL WITH A LONG ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 13384920 ↗
• InjuryMay 20, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 5 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT FOR A SUSPECTED INFECTION. INFECTION FOUND AT SOFT TISSUE LEVEL. THE SURGEON REVISED SUCCESSFULLY ALL THE COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER [PATHOGEN: STAPHYLOCOCCUS AUREUS].

  Patient problems: Unspecified Infection

  MAUDE report 8623893 ↗
• InjuryAug 30, 2018Fracture

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 MONTHS AND HALF AFTER THE PRIMARY. THE SURGEON DETERMINED THAT THE FEMUR WAS FRACTURED. THERE WAS NO REPORT OF TRAUMA. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7832914 ↗