MiniMAX Stems 01.13.107LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030803277), received between Jun 16, 2020 and Jun 16, 2020 — classified as 2 injuries.

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.

• InjuryJun 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10157892 ↗
• InjuryJun 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 7 MONTHS AFTER THE PRIMARY SURGERY REPORTING DISCOMFORT WHILE AMBULATING. DURING A POST-OP VISIT THE SURGEON OBSERVED THAT THE FEMORAL COMPONENT WAS IN 9° VALGUS. THERE WAS ZERO DEGREES OF VARUS PLANNED, PROBABLY IT IS THE CAUSE OF THE POSITIONING OF THE IMPLANT DURING THE PRIMARY SURGERY. THE PATIENT WAS MECHANICALLY ALIGNED. THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY FROM A SPHERE TO A SEMI-CONSTRAINED. TIBIAL COMPONENT WAS NOT REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10157890 ↗