MiniMAX Stems 01.13.103RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030803208), received between Mar 16, 2018 and Aug 22, 2024 — classified as 5 injuries.

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

• InjuryAug 22, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAS A PRIMARY HIP SURGERY ON (B)(6) 2016. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. ON (B)(6) 2021, THE SURGEON REVISED THE STEM, HEAD AND LINER. (MDR 2021-00641) (B)(6) 2024: THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM, AND REVISED THE MEDACTA HEAD AND LINER WITH ANOTHER MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20033012 ↗
• InjuryJun 18, 2019Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A FEMUR SPIRAL FRACTURE 3 DAYS AFTER SURGERY. THE REASON OF FRACTURE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE PATIENT SWAPPING THE STEM AND THE CERAMIC HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 8707192 ↗
• InjuryJun 11, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 2 WEEKS AFTER THE PRIMARY DUE TO BONE FRACTURE AND SUBSIDED STEM. THE PATIENT WAS WALKING TO THE BATHROOM AND FELT A CRACK IN HER HIP, COULD THEN NOT WEIGHT BARE. THE MINI MAX STEM HAS BEEN REMOVED, IMPLANTED A XACTA 37.5MM AND A NEW HEAD, PLUS 3 CABLES.

  Patient problems: Bone Fracture(s)

  MAUDE report 8685954 ↗
• InjuryNov 20, 2018Fracture

  9 DAYS POST PRIMARY, AFTER A SESSION OF PHYSIOTHERAPY, THE PATIENT HAS FELT SEVERE PAIN AND COULD NOT STAND. X-RAY REVEALED A PERIPROSTHETIC FRACTURE, SO ON THE NEXT DAY THE PATIENT UNDERWENT TO A REVISION SURGERY: THE FEMUR WAS CABLED WITH 2 CERCLAGE WIRES AND THE STEM WAS CONVERTED TO QUADRA STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS NOT BELIEVED THAT THE FRACTURE HAD BEEN DUE TO AGGRESSIVE PHYSIOTHERAPY, BUT THEY BELIEVED THAT IT COULD HAVE BEEN DUE TO RAPID RECOVERY OF THE PATIENT COUPLED WITH AN INITIAL VALGUS POSITION AND UNDERSIZED STEM - THAT MIGHT HAVE SUBSIDED DUE TO VERY EARLY MOBILIZATION INTO NEUTRAL/VARUS POSITION (AND THEN BECAME "OVERSIZED" HAVE CONTRIBUTED TO THE FRACTURE).

  Patient problems: Bone Fracture(s)

  MAUDE report 8089816 ↗
• InjuryMar 16, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE HIP AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7344708 ↗