MiniMAX Stems 01.13.105RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030803246), received between Jul 27, 2018 and Jul 17, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  9 MONTHS AFTER PRIMARY SURGERY, REVISION SURGERY PERFORMED FOR STEM LOOSENING. STEM AND CERAMIC HEAD REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10288608 ↗
• InjuryOct 23, 2019Fracture

  3 WEEKS POST-OP PATIENT SUFFERED A SPIRAL FRACTURE OF HER FEMUR. CABLES WERE USED TO REDUCE THE FRACTURE. THE STEM WAS NOT EXPLANTED BUT LEFT IN PLACE. THE HEAD WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9224411 ↗
• InjuryJul 12, 2019Fracture; Device Slipped

  REVISION SURGERY PERFORMED 10 MONTHS AFTER PRIMARY SURGERY DUE TO A SMALL FRACTURE IN PROXIMAL FEMUR PROBABLY OCCURRED DURING THE PRIMARY SURGERY WHICH CAUSED THE STEM TO SLIDE INTO A VALGUS POSITION. THE REVISION SURGERY WAS COMPLETED AND THE STEM WAS REVISED.

  Patient problems: Hip Fracture

  MAUDE report 8784033 ↗
• InjuryJul 31, 2018Loss of or Failure to Bond

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM HAD SUBSIDED. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7734723 ↗
• InjuryJul 27, 2018Fracture; Loose or Intermittent Connection

  ON (B)(6) 2018 WE WERE INFORMED BY THE SURGEON ABOUT A METAPHYSEAL PERIPROSTHETIC FRACTURE, IDENTIFIED ON A PATIENT OPERATED ON (B)(6) 2018 THROUGH AMIS APPROACH. STARTING FROM (B)(6) 2018, THE PATIENT REPORTED HIP PAIN AND, AFTER HAVING ANALYZED DETAILED EXAMS (X-RAYS AND TAC IMAGES), THE SURGEON NOTICED A METAPHYSEAL FEMORAL FRACTURE WHICH CAUSED STEM LOOSENING. THE SURGEON E-OPERATED THE PATIENT ON (B)(6) 2018 (THROUGH AMIS APPROACH): AFTER HAVING EASILY REMOVED THE HIP STEM, THE SURGEON FIXED THE FRACTURE THROUGH 3 METAPHYSEAL BONE CERCLAGES. FINALLY, HE IMPLANTED A QUADRA-R STEM, ALSO CHANGING THE FEMORAL BALL HEAD.

  Patient problems: Joint Disorder

  MAUDE report 7726660 ↗