MiniMAX Stems 01.13.102LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030803178), received between Dec 19, 2017 and Apr 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2022Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN WAS UNKNOWN. AT 2 WEEKS FORM PRIMARY THE SURGEON DETERMINED THAT THE PATIENTS STEM WAS UNDERSIZED AND THE FEMUR BONE FRACTURED. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14165859 ↗
• MalfunctionDec 19, 2017Packaging Problem; Packaging Problem

  DURING SURGERY SURGEON OPENED A FIRST PACKAGING AND FOUND THE STEM NOT IN PLACE AND THE BROKEN BLISTER. THE SURGEON OPENED A SECOND PACKAGING AND HE FOUND THAT THE STEM WAS NOT IN THE CORRECT POSITION AND HE FOUND SCRATCHES ON THE BLISTER. THE SURGEON USED THE SECOND STEM AVAILABLE IN THE ROOM SINCE HE DID NOT HAVE OTHER BACK-UP. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 7129081 ↗