BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 47Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 03662200015641), received between Jul 6, 2021 and Dec 16, 2025 — classified as 38 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CUP AND LINER INSTABILITY, 25MM SCREW HEAD BROKE OFF WHEN TRYING TO EXTRACT SCREW. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23822099 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT OCCURED A REVISION OF THE PE LINER OF THE LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23726400 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT OCCURED SIGNS OF INFECTIONS LEADING TO WASH OUT AND REVISION OF THE POLYETHYLENE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 22438251 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOWING EARLY SIGNS OF INFECTION. HEAD AND LINER SWAP WAS DONE OUT OF AN ABUNDANCE OF CAUTION WHILE PERFORMING THE I&D FOR A POSSIBLY INFECTED HIP. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22422515 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): SERF RC-24-0231 PATIENT WAS REVISED DUE TO INFECTION. WASH OUT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 21230587 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  (B)(4): (B)(6) PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21230327 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  (B)(4): (B)(6) 2023 PATIENT WAS REVISED DUE TO WASH OUT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21229860 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): (B)(6) PATIENT WAS REVISED DUE TO MAJOR SPINE HARDWARE AND PELVIC MOBILITY ISSUES. PATIENT DISLOCATED AND CUP BECAME UNSTABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226116 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): SERF RC-24-0205 PATIENT WAS REVISED DUE TO DISLOCATION. BI-MENTUM LINER POPPED OFF OF 28 HEAD WHEN IT DISLOCATED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226108 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21225992 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): SERF 39-2023 PATIENT WAS REVISED DUE TO DISLOCATION. SURGICAL DELAY UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21225351 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH HIP PAIN AND INABILITY TO BEAR WEIGHT. XRAYS SHOWED THAT THE ACETABULAR SHELL WAS NO LONGER IN PLACE AND IS THROUGH THE MEDIAL WALL. THERE WAS NON-CEMENTED LOOSENING OF THE ACETABULAR SHELL. THE PATIENT WAS ADMITTED AND SCHEDULED FOR SURGERY TO REMOVE EXISTING COMPONENTS. NO DELAY OR HARM WAS NOTED. THE PROXIMAL FEMORAL COMPONENT TO INCLUDE THE HEAD AND DM POLY LINER WERE REMOVED. ACETABULAR COMPONENT WAS ALSO REMOVED WITH NO COMPLICATION. DUE TO LACK OF BONE STOCK, NO COMPONENTS WERE REPLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20877847 ↗
• InjuryNov 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR THE REVISION ON (B)(6)2024. AS REPORTED: "PATIENT HAD REVISION SURGERY FOR DISLOCATION ON (B)(6) 2022 TO DUAL MOBILITY LINER. SHE WAS REVISED TO CONSTRAINED LINER ON (B)(6) 2024. NO OTHER INFO AVAILABLE."

  Patient problems: Joint Dislocation

  MAUDE report 20769971 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION SURGERY FOR DISLOCATION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20479667 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INSTABILITY & PAIN

  Patient problems: Joint Laxity; Pain

  MAUDE report 18978412 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS (B)(4) WERE REVIEWED BY CLINICIAN. ON (B)(6) 2023, THE PATIENT HAD A LEFT HIP ASPIRATE FOR LAB TESTING. THE PATIENT WAS REPORTED TO HAVE LEFT HIP PAIN. THE PATIENT REPORTS THAT THEIR HIP IS NOT PUFFY. CHROMIUM WAS NOTED TO BE 11.7 NG/ML AND COBALT 14.4 NG/ML. ON (B)(6) 2024 THE PATIENT WAS REPORTED TO HAVE A LEFT TOTAL HIP ARTHROPLASTY REMOVAL OF CUP AND STEM AND LEFT HIP INSERTION OF ANTIBIOTIC CEMENT SPACER. THE FINDINGS INCLUDED LEFT HIP METALLOSIS WITH BLACK/BROWN DEBRIS AND PURULENT MATERIAL UNDER THE LINER. IT WAS NOTED THAT THE FEMORAL STEM WAS WELL FIXED AND AN EXTENDED TROCHANTERIC OSTEOTOMY WAS NEEDED FOR REMOVAL AND IT TOOK 2 HOURS. DURING THE PROCEDURE, THE SURGEON OBSERVED PROXIMAL OSTEOLYSIS. TWO DALL MILES CABLES WERE PLACED AROUND PROXIMAL FEMUR TO REDUCE THE ETO FRAGMENTS TO THE SPACER. THE PATHOLOGY RECORDS REPORT THE DEPUY PRODUCTS REMOVED. MEDICAL/SURGICAL NOTES HAD DISCREPANCIES IN THE SIDE OF THE OPERATION, WITH PART OF THE SURGICAL NOTE STATING THAT THE SURGERY WAS ON THE RIGHT SIDE AND PART OF THE SAME SURGERY NOTES STATING THAT IT WAS THE LEFT. THERE WAS ZERO MENTION OF IT BEING BILATERAL.

  Patient problems: Erythema; Fall; Fatigue; Fluid Discharge; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 18912579 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18722120 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. BI-MENTUM LINER POPPED OFF OF 28 HEAD WHEN IT DISLOCATED. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18493729 ↗
• InjuryOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022, DOR- (B)(6) 2023, AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 17967224 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: JULY 10,2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17825468 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MAJOR SPINE HARDWARE AND PELVIC MOBILITY ISSUES. PATIENT DISLOCATED AND CUP BECAME UNSTABLE. DOI: UNKNOWN DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17434568 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17390999 ↗
• InjuryApr 28, 2023Adverse 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: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16831259 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO DEPUY INSTRUMENTATION THAT BROKE.

  Patient problems: Joint Dislocation

  MAUDE report 16706788 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO WASH OUT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16395556 ↗