MiniMAX Stems 01.13.105LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030803239), received between Jan 3, 2018 and Jun 26, 2025 — classified as 8 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 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY TOTAL HIP ARTHROPLASTY (THA) IN 2021, THE PATIENT SUSTAINED A FRACTURE THAT WAS TREATED WITH CERCLAGE. FROM THE OUTSET, SHE EXPERIENCED LIMPING AND PAIN, WHICH EVENTUALLY LED TO A REVISION OF THE IMPLANT AT 3 YEARS AND 11 MONTHS POST PRIMARY. DURING THE REMOVAL, THE MINIMAX STEM, DESPITE THE ABSENCE OF A LARGE PORTION OF THE GREATER TROCHANTER AND THE PROXIMAL PERIPROSTHETIC BONE, WAS FOUND TO BE VERY STABLE. IT WAS REPLACED WITH A MODULAR M-VIZION STEM. THE ACETABULAR COMPONENT WAS LEFT UNTOUCHED, AS IT WAS FOUND TO BE INTACT AND STABLE.

  Patient problems: Pain

  MAUDE report 22334724 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM WHERE DURING THE REVISION SURGERY AN OSTEOTOMY OF THE FEMUR TO REMOVE THE STEM WAS NECESSARY. THE SURGEON USED CABLES AND REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR. THE SURGEON REVISED THE STEM WITH A COMPETITOR STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15444795 ↗
• InjuryDec 9, 2020Migration; Migration

  4 WEEKS AFTER PRIMARY THR. PATIENT CAME TO THE CLINIC COMPLAINING ON PAIN. X-RAYS SHOW SUBSIDENCE OF THE FEMORAL STEM AND FRACTURE OF THE CALCAR. REVISION OF THE STEM PERFORMED WITH DIFFERENT MANUFACTURER STEM. IT SHOULD BE NOTED THAT THE PATIENT HAS SEVERE OSTEOPOROSIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 10975810 ↗
• InjuryFeb 21, 2020Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED 3 DAYS AFTER PRIMARY DUE TO HIP DISLOCATION (HEAD FROM LINER, CERAMIC ON CERAMIC) PROBABLY DUE TO STEM SINKING. THE MINIMAX STEM WAS REMOVED AND A CEMENTED X-ACTA SHORT WAS IMPLANTED. THE PATIENT WAS OPERATED IN PRIMARY DUE TO BONE FEMUR FRACTURE.

  Patient problems: Joint Disorder

  MAUDE report 9738554 ↗
• InjuryJul 3, 2019Fracture

  REVISION SURGERY PERFORMED 14 DAYS AFTER THE PRIMARY DUE TO PAIN CAUSED BY A FRACTURED FEMUR AND SUBSIDED STEM (THE CAUSE OF THE FRACTURE IS UNKNOWN). THE SURGEON REVISED THE STEM AND THE HEAD AND CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8757404 ↗
• InjuryJan 11, 2019Inadequacy of Device Shape and/or Size

  REVISION SURGERY 1 MONTH AFTER PRIMARY SURGERY. THE STEM WAS TOO DEEP INSIDE THE FEMORAL BONE. STEM AND HEAD WERE REVISED. THE STEM LOOKS SLIGHTLY UNDERSIZED BASED ON RADIOGRAPHIC ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8239869 ↗
• InjuryJul 20, 2018Fracture

  POST-OP THE SURGEON NOTICED THAT THE PATIENT HAD A FRACTURE ON THE FEMUR. THE SURGEON WENT BACK IN ON THE SAME DAY TO REVISE THE PATIENT. STEM, HEAD AND BIPOLAR HEAD WERE REPLACED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7706398 ↗
• InjuryJan 3, 2018Unsealed Device Packaging

  DURING THE IMPLANT OPENING THE PRIMARY PACKAGING BLISTER RESULTED SCRATCHED AND BROKEN. A BACK-UP STEM WAS OPENED. THE SECOND STEM HAD THE PRIMARY PACKAGING BLISTER SCRATCHED BUT NOT BROKEN AND THE SURGEON CONSIDERED IT SAFE FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7160287 ↗