MiniMAX Stems 01.13.102RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030803185), received between Jul 15, 2019 and Mar 13, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16, 2026.

Recalls naming this device

1. Nov 15, 2017Terminated

   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.

• InjuryMar 13, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. ON (B)(6) 2024, THE SURGEON REVISED THE MEDACTA STEM, HEAD AND LINER WITH ANOTHER MEDACTA STEM, HEAD AND LINER. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21591415 ↗
• InjuryJul 11, 2024Osseointegration Problem; Osseointegration Problem

  MINIMAX STEM MOBILIZED AND ROTATED IN THE PATIENT'S FEMUR. STEM AND HEAD REVISED AT ABOUT 3 MONTHS FROM THE PREVIOUS REVISION SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19719882 ↗
• InjuryJul 3, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING A LEG LENGTH DISCREPANCY THAT WAS CAUSED BY A SUBSIDED STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10229609 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2019 WE WERE ALERTED OF A REVISION PERFORMED ON (B)(6) 2019. REVISION SURGERY HAS BEEN PERFORMED 6 MONTHS AFTER PRIMARY DUE TO LEG LENGTH DISCREPANCY, 15 MM (APPARENTLY DUE TO SEVERE SCOLIOSIS OF THE SPINE). THROUGH A POSTERIOR APPROACH THE SURGEON REMOVED THE STEM, LINER AND HEAD. HE REPLACED THESE EXPLANTED ITEMS WITH AN MPACT HOODED LINER AND A COMPETITOR REVISION STEM AND HEAD.

  Patient problems: Joint Disorder

  MAUDE report 8789471 ↗