BI-MENTUM ALTRX 122122041Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295525356), received between Jun 20, 2023 and Sep 3, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50595661 ↗
• InjuryMar 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. THEY WERE CONVERTED TO A CONSTRAINED LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24570395 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON WASHED OUT DIS POLY LINER SWAP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23888045 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23865833 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTED HIP 2 + YEARS POST THA. ALL WELL-FIXED COMPONENTS WERE REMOVED AND A PROSTALAC WAS PLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23584369 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22574960 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN . DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21172431 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THERE WAS NO SURGICAL DELAY. WHAT IS THE REASON FOR REVISION? INFECTION. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS/CONSEQUENCES THAT LED TO THE REVISION SURGERY? INFECTION. WAS THERE AN INFECTION THAT LEAD TO THE WASHOUT? YES.

  Patient problems: Unspecified Infection

  MAUDE report 19280377 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM, THIGH PAIN. DONE ELSE WHERE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 18685549 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A FRACTURE AT GREATER TROCH, POSSIBLE INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18444024 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REASON FOR REVISION WAS SURGEON SUSPICION OF INFECTION. IT IS UNKNOWN IN INFECTION WAS PRESENT OR NOT. THE PINNACLE DUAL MOBILITY METAL LINER, POLY LINER AND METAL HEAD WERE REMOVED BEFORE I&D. NEW IMPLANTS OF THE SAME SIZES WERE THEN IMPLANTED. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17208123 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17198981 ↗
• InjuryJun 20, 2023Off-Label Use; Off-Label Use

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. LINER AND HEAD WERE EXCHANGED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17163899 ↗