BI-MENTUM ALTRX 122122043Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295525363), received between Jun 23, 2023 and Sep 2, 2026 — classified as 12 injuries.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50569570 ↗
• InjurySep 1, 2026Device Dislodged or Dislocated

  It was reported that the patient came in because of dislocation. Doctor tried to do a closed reduction and was unable to reduce the hip. The surgeon decided to do an open reduction and doing so the doctor wanted to replace the old 22.2 head and the dual mobility head. The patient also had multilevel spinal fusion.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50546702 ↗
• InjuryJul 29, 2026Device Dislodged or Dislocated

  It was reported that dislocating hip.DOI: UnknownDOR: (b)(6)2026Affected Side: Left Hip

  Patient problems: Joint Dislocation

  MAUDE report 50077796 ↗
• InjuryApr 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTED IN OFFICE FOR FOLLOW UP POST DISLOCATION AND PAIN. X-RAYS REVEALED ECCENTRICITY OF THE IMPLANT POST HIP RELOCATION AND THE SURGEON SUSPECTED A HEAD-LINER DISASSOCIATION DURING THE ATTEMPTED RELOCATION. REVISION TOTAL HIP ARTHROPLASTY WAS SCHEDULED, AND INTRAOPERATIVELY, THE POLY LINER WAS FOUND DISASSOCIATED WITH LOOSENING AT THE NON-CEMENTED INTERFACE. BOTH THE LINER AND A WELL-FIXED FEMORAL HEAD WERE REMOVED DUE TO POTENTIAL DAMAGE, ALONG WITH THE METAL DM LINER. NEW COMPONENTS WERE IMPLANTED WITHOUT DELAY OR PATIENT HARM, AND HIP RANGE OF MOTION WAS STABLE POST-PROCEDURE. IT IS BELIEVED THE POLY LINER DISASSOCIATION OCCURRED DURING THE ATTEMPTED RELOCATION, AS PREVIOUS IMAGING SHOWED ALL COMPONENTS WELL FIXED AND FUNCTIONING. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 24971632 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL HIP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 23572163 ↗
• InjurySep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED, SHOWED UP TO DR OFFICE, SCHEDULE THE REVISION (B)(6). FOUND THAT THE 22 CERAMIC HEAD CHIPPED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22976228 ↗
• InjuryAug 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SO WENT TO CONSTRAINED LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22750907 ↗
• InjuryJun 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22331936 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED EXPLANTED / DUE TO INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21662150 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THESE IMPLANTS DUE TO INFECTION, THEN THE SURGEON REPLACED THEM WITH NEW ONES. THE CUP AND SCREWS FROM THE PRIMARY SURGERY WERE LEFT IMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20370989 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, WASHED IT OUT, REMOVED DUAL MOBILITY LINER AND SHELL. RE-IMPLANTED SAME IMPLANTS AND CLOSED THE PATIENT UP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20189190 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17191432 ↗