MiniMAX Stems 01.13.104LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030803215), received between Nov 7, 2018 and Jun 24, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2021Loose or Intermittent Connection

  THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2017. ON (B)(6) 2020, THE PATIENT CAME IN THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM (UNKNOWN CAUSE). THE SURGEON REVISED THE STEM, HEAD, AND LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12056288 ↗
• InjuryFeb 20, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A FRACTURED FEMUR. THE FRACTURED FEMUR OCCURRED AS A RESULT OF A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9731550 ↗
• InjuryDec 10, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A FRACTURED FEMUR. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEAM AND LINER 4 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9443537 ↗
• InjuryJul 23, 2019Fracture

  REVISION SURGERY PERFORMED 15 DAYS AFTER THE PRIMARY DUE TO PAIN CAUSED BY A FRACTURED FEMUR, WHICH OCCURRED WHILE PUTTING ON HIS PANTS(NO FALL OCCURRED, THE PATIENT PLACED BODY WEIGHT ON ONE LEG WHILE ATTEMPTING TO PLACE THE OTHER LEG IN PANT LEG WHEN POP WAS HEARD AND PAIN OCCURRED). THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8816677 ↗
• InjuryNov 16, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 2 MONTHS AFTER PRIMARY DUE TO BONE FEMUR FRACTURE. THE SURGEON REVISED THE STEM, HEAD AND LINER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8077512 ↗
• InjuryNov 7, 2018Break; Break

  WE WERE INFORMED ON (B)(4) 2018 THAT ON (B)(6) 2018 THE PATIENT WENT TO THE HOSPITAL SINCE HE HEARD A NOISE AND THE ARTICULATION IS NOT STABLE. PATIENT WAS REVISED DUE TO HIP LUXATION IN 2013, CUP, HEAD AND LINER WERE REMOVED. IN 2018 THE PATIENT WAS REVISED AGAIN DUE TO NECK STEM BREAKAGE. STEM AND HEAD WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 8045556 ↗