BI-MENTUM ALTRX 122128047Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295525349), received between Sep 22, 2023 and Sep 28, 2026 — classified as 26 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient developed an infection. The liner and head were exchanged.Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50917934 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that there a revision occurred due to dislocation and a need for a dual mobility bearing. The stem was a competitor product.DOI: (b)(6) 2022.DOR: (b)(6) 2026.Affected side: Right hip.

  Patient problems: Joint Dislocation

  MAUDE report 50756320 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25461308 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HIP REVISION DONE THE WEEK PRIOR AND THEY DISLOCATED POST OP WHILE STILL IN THE HOSPITAL. SURGEON OBSERVED THE PATIENT FOR A FEW DAYS, AND WHEN THEY DISLOCATED AGAIN, DECIDED TO REVISE. CHANGED OUT THE LINER/HEAD AND WENT WITH A LONGER HEAD; WAS VERY STABLE ON THE OR TABLE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24627778 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24214817 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23961365 ↗
• InjuryDec 19, 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: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23853657 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE SURGEON PERFORMED HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23837551 ↗
• InjuryDec 1, 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. DOCTOR DID I&D HEADBALL LINER SWAP. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23686878 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23479016 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE SURGEON PERFORMED A HIP WASH OUT AND EXCHANGED BIMENTUM LINER AND HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23284977 ↗
• InjurySep 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND WENT TO 36 DM LONGER HEAD. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23040060 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO EARLY INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22879736 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO EARLY INFECTION. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22879731 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CONVERSION FROM A GAMMA NAIL TO A THR. PATIENT GOT INFECTED 6 WEEKS POSTOPERATIVELY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22819973 ↗
• InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE A MONTH AGO AND HAD FALLEN AND DISLOCATED TO HIP. SURGEON ELECTED TO CONVERT HER TO. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22811641 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AFTER PRIMARY THA. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22688833 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT I/D WASHOUT. PATIENT WAS INFECTED. THERE WAS NO COMPLICATIONS DURING SURGERY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22632461 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21698955 ↗
• InjuryMar 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS BEEN REVISED BEFORE SOMEWHERE ELSE FOR DISLOCATION. SHE DISLOCATED AGAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21621542 ↗
• InjuryMar 7, 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 PAIN. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21548453 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. UPON X-RAY, CUP FOUND TO HAVE BECOME LOOSE AND SHIFTED DUE TO A FRACTURE IN THE ACETABULAR AREA NOT RELATED TO SURGERY. STEM WAS WELL FIXED AND DID NOT REPLACE. SURGEON REAMED UP AND PLACED A MULTI HOLE CUP AND DUAL MOBILITY SYSTEM. PATIENT WAS LEFT SURGERY WILL FIXED AND STABLE. SURGEON WAS SATISFIED WITH SUCCESSFUL SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21255104 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHICH HAS MADE THEM VERY ILL. INFECTION IN THE JOINT HAS SINCE DEVELOPED, AS SURGEON NOTED PATIENT HAD BEEN DOING WELL BEFORE THE ABOVE INFECTION. A REVISION OF RIGHT THA DUE TO INFECTION FOLLOWING A DAIR WAS PERFORMED. PATIENT STILL HAD INFECTION AND REQUIRED FIRST STAGE REVISION TO REMOVE ALL COMPONENTS, WASH OUT AND DEBRIDEMENT. CEMENTED A 52 LINER AND SIZE 1 C STEM PLACED FOR APPROXIMATELY 6 WEEKS, AND WILL THEN FULLY REVISE.

  Patient problems: Unspecified Infection

  MAUDE report 21138857 ↗
• InjurySep 13, 2024Off-Label Use; Off-Label Use

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING TREATMENT/IMPACT ON THE PATIENT. ON IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 20213689 ↗
• MalfunctionJan 22, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552368 ↗