MiniMAX Stems 01.13.108LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030803291), received between Dec 22, 2017 and Feb 9, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2018Packaging Problem; Packaging Problem

  DURING SURGERY THE STEM PACKAGING WAS FOUND DAMAGED AND BROKEN (HOLE). A SECOND STEM OF THE SAME SIZE WAS OPENED: THE PACKAGING WAS DAMAGED, BUT IN BETTER CONDITION COMPARED TO THE PREVIOUS ONE, SO IT WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 7258659 ↗
• InjuryDec 22, 2017Appropriate Device Problem Term/Code Not Available

  FOLLOWING THE PRIMARY SURGERY THE REVIEW OF THE PATIENT DISCOVERED THAT THE STEM HAD SUBSIDED AND A GREATER TROCHANTERIC FRACTURE WAS PRESENT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY USING A REVISION STEM AND CABLES. AS THE ACETABULUM IS A DM CUP A NEW LINER AND CERAMIC HAD WAS ALSO IMPLANTED. ALTHOUGH SUBSIDED, THE STEM DISPLAYED EXCELLENT ON-GROWTH AND STABILITY WITHIN THE CANAL AS SUCH IT WAS DIFFICULT TO EXPLANT. THE CUP WAS NOT TOUCHED.

  Patient problems: Joint Disorder

  MAUDE report 7142941 ↗