BI-MENTUM ALTRX 122128051Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295525233), received between Oct 26, 2023 and Nov 20, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23606119 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22589330 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND THE ACETABULAR COMPONENTS WERE REMOVED & REPLACED DUE TO CONTINUOUS DISLOCATION OF THE HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22411084 ↗
• InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATION OCCURRED. UPON TRYING TO REDUCE IN THE ER, FEMUR FRACTURED BELOW THE STEM.

  Patient problems: Joint Dislocation

  MAUDE report 22236472 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION OF A RECLAIM BIMENTUM WAS DONE. THE REASON FOR REVISION WAS DUE TO INSTABILITY. THE PATIENT PREVIOUSLY HAD A GIRDLESTONE PROCEDURE, AND WAS LIKE THAT FOR A NUMBER OF YEARS. THE SURGEON NOTED THAT DURING THE PRIMARY SURGERY THEY WERE STABLE ON THE TABLE WITH A 24X95 RECLAIM BODY, BUT THEIR ADDUCTOR MUSCLES WERE GONE, AND SURROUNDING TISSUES WERE DYSFUNCTIONAL. AT SOME POINT AFTER SURGERY PATIENT MOVED INTO A POSITION (WHICH THE SURGEON ADVISED NOT TO) AND THEY DISLOCATED. THE RECLAIM BODY, BIMENTUM POLY AND 28+8.5 CERAMIC HEAD WERE REMOVED. CUP WAS RETAINED. THEN A LONGER BODY, NEW POLY AND 28+12 HEAD WERE IMPLANTED. THE SURGEON SAID THAT THE PATIENT'S SOFT TISSUES ARE VERY POOR, AND THEY HAVE NO ADDUCTOR MUSCLES. NO PREVIOUS REVISION HAD BEEN DONE FOR DISLOCATIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21696089 ↗
• InjuryFeb 10, 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 INFECTION AND THE SURGEON DID A SINGLE STAGE REVISION. SURGEON REMOVED ALL IMPLANTS, DID A THOROUGH I&D, AND PUT IN NEW IMPLANTS. THERE WAS NO DELAY IN PROCEDURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21342942 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21170374 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CORAIL SIZE 14 STD OFFSET IMPLANTED AND SIZE 60 CUP. PATIENT HAD UNDERGONE DAIR PROCEDURE FOR INFECTION IN LATE AUGUST, THIS HAD NOT REMOVED THE INFECTION SO IT WAS DECIDED THAT A FULL REVISION PROCEDURE BE CARRIED OUT. ALL IMPLANTS WERE REMOVED AND RECLAIM WITH MULTIHOLE CUP AND DUAL MOBILITY WAS IMPLANTED AS PART OF THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 21073927 ↗
• InjuryOct 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A ONKOS CUSTOM TRIFLANGE DESIGNED FOR THEM. THE SURGEON CEMENTED IN A BIMENTUM CUP ALONG WITH A DUAL MOBILITY INSTRUCT. THE PATIENT DISLOCATED AND SURGEON WANTED TO GO IN AND ADD LENGTH TO THE DUAL MOBILITY CONSTRUCT. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20494285 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO HARM, NO BROKEN INSTRUMENT, NO DELAYS. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20078312 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP PROSTHESES WERE REMOVED AND A PROSTALAC WAS PLACED UNEVENTFULLY AFTER A THOROUGH DEBRIDEMENT AND I&D WERE PERFORMED. THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON (B)(4) 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. DOI: (B)(6) 2023 (OTHER IMPLANTS). DOI: (B)(6) 2023. (THE HEAD AND DM POLY LINER). DOR: (B)(6), 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18320095 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THAT THE PATIENT LEANS FORWARD TO GET OUT OF BED AND PUSHES HIS HIP OUT THE BACK. PATIENT HAS A FUSED SPINE AND HIGH DISLOCATION RISK PATIENT PER THE SURGEON. SURGEON ELECTED TO CHANGE DUAL MOBILITY LINER AND LENGTHEN THE HEAD BALL. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18278219 ↗
• InjuryOct 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT DISLOCATION OCCURRED BETWEEN THE LINER AND HEAD. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18010845 ↗