BI-MENTUM ALTRX 122122045Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295525370), received between Jan 10, 2024 and Sep 11, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Naturally Worn

  It was reported that patient was revised due to revision poly exchange for excessive poly wear.DOI: UnknownDOR: UnknownAffected side: Left.

  Patient problems: Insufficient Information

  MAUDE report 50732546 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. DOCTOR DID WASH OUT AND SWAPPED HEADS. THERE WAS NO DELAY AND NO PROBLEM WITH IMPLANTS. THERE WAS NO ADDITIONAL INFORMATION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24498343 ↗
• InjuryJan 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24115640 ↗
• InjurySep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND CONVERTED TO A CONSTRAINED LINER. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 23027268 ↗
• MalfunctionMay 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DUE TO THE DEFECTIVE TOWER USED ON THIS CASE CAUSED THIS LINER TO DROP IN THE FLOOR RESULTING IN A 30 MINUTE DELAY AS THEY HAD TO RUSH TO STORAGE TO GET THE REPLACEMENT IMPLANT TO BE IMPLANTED. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 22107174 ↗
• InjuryJan 3, 2025Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION, CUP WAS TOO RETROVERTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21067693 ↗
• InjuryOct 8, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH DRAINAGE POST THA AFTER BEING DIAGNOSED WITH UNCONTROLLED DIABETES. PATIENT ALSO HAS CIRRHOSIS OF THE LIVER. AN I&D WITH MODULAR COMPONENT EXCHANGE WAS PERFORMED WITHOUT DELAY NOR PATIENT HARM. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20400350 ↗
• InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT COMPLAINS OF REPEATED DISLOCATIONS. CUP REVISION PLANNED WITH COMPETITIVE COMPANY. CUP FOUND TO HAVE EXCESSIVE ANTEVERSION ACCORDING TO OPERATING SURGEON. CUP THEN FOUND TO BE LOOSE AT NON-CEMENTED INTERFACE ONCE ATTEMPTING TO USE CUP CUTTER. EXPLANTED SHELL SHOW NO OSTEOINTEGRATION. THERE WAS NO DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19220924 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION AND NEW IMPLANTS WERE IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18987533 ↗
• InjuryMar 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RECEIVED A THA (B)(6) 2024 AFTER A NAIL REMOVAL THAT CUT THROUGH THE FEMORAL HEAD. PATIENT FELL ON (B)(6) AND DISLOCATED HER HIP. THEY WERE NOT ABLE TO REDUCE IN THE ED SO BROUGHT BACK TO OR. APPEARED STEM SUBSIDED FROM FALL AND WAS LOOSE. STEM AND DUAL MOBILITY WAS REVISED TO CEMENTED ENDURANCE STEM AND CONSTRAINED LINER. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE : RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18893535 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION AND WAS CONVERTED TO A CONSTRAINED LINER UNEVENTFULLY. NO PATIENT HARM OCCURRED AND DELAY WAS EXPERIENCED. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18490227 ↗