MiniMAX Stems 01.13.106LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030803253), received between Nov 10, 2017 and Jun 14, 2023 — classified as 3 injuries, 1 malfunction.

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.

• InjuryJun 14, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 1 YEAR 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17123885 ↗
• InjuryApr 9, 2021Fracture

  2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A PREPROSTHETIC FEMUR FRACTURE THAT WAS CAUSED BY DISMOUNTING A HORSE(NO TRAUMA). THE SURGEON CABLED THE FRACTURE, REVISED THE STEM AND HEAD WITH A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11640105 ↗
• MalfunctionNov 17, 2017Packaging Problem; Packaging Problem

  DURING THE STEM IMPLANTATION, THE SURGEON NOTICED THAT THE DEVICE'S PRIMARY PACKAGING WAS DAMAGED, IT PRESENTED AN HOLE. THE SURGEON REMOVED THE STEM FROM THE FEMUR AND WAITED THE ARRIVAL OF THE BACK-UP IMPLANT TRANSPORTED IN URGENCY FROM THE MEDACTA (B)(4) WAREHOUSE. THIS EVENT CAUSED A CRITICAL DELAY IN THE SURGERY THAT WAS ANYWAY COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040109 ↗
• InjuryNov 10, 2017Fracture; Loose or Intermittent Connection

  REVISION SURGERY WAS NECESSARY 21 DAYS AFTER PRIMARY. THE STEM WAS LOOSE AND IT WAS FOUND THAT THERE WAS A BONE FRACTURE. NO TRAUMA REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7018029 ↗