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BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 51Recalls & reported problems

Soc Etudes Recherches Fabrication · BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner · Class 2 · Implant

All models of BI-MENTUM PE Liner (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03662200015665), received between Mar 31, 2021 and Sep 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem8
  • Device Dislodged or Dislocated1
  • Insufficient Device Problem Information1

Patient problems

  • Pain4
  • Unspecified Infection4
  • Insufficient Information2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Joint Dislocation1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjurySep 11, 2025Adverse 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) 2025. AFFECTED SIDE: RIGHT HIP.

    Patient problems: Pain

    MAUDE report 23030723 ↗
  • InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    (B)(4): (B)(6) "THE PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY."

    Patient problems: Insufficient Information; Pain

    MAUDE report 21230326 ↗
  • 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) THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. UNKNOWN SURGICAL DELAY.

    Patient problems: Insufficient Information; Pain; Unspecified Infection

    MAUDE report 21230148 ↗
  • InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT PRESENTED WITH INFECTION SO REMOVED ALL IMPLANTS TO ALLOW FOR INFECTION TO CLEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023, DOR: UNKNOWN, AFFECTED SIDE: LEFT HIP.

    Patient problems: Unspecified Infection

    MAUDE report 18138842 ↗
  • InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

    Patient problems: Pain

    MAUDE report 17701897 ↗
  • InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED DUE TO CHRONIC INFECTION. REMOVAL OF ALL IMPLANTS TOOK PLACE. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

    Patient problems: Unspecified Infection

    MAUDE report 16777449 ↗
  • InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT HEAD & LINER EXCHANGE DUE TO INFECTION. NEW HEAD AND LINER IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

    Patient problems: Unspecified Infection

    MAUDE report 15240548 ↗
  • InjuryDec 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI : UNKNOWN DOR : (B)(6) 2021 RIGHT HIP.

    Patient problems: Joint Dislocation

    MAUDE report 12917094 ↗
  • InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DUAL MOBILITY COMPONENTS REVISED FOR EARLY INFECTION. DOI: (B)(6) 2021: DOR: (B)(6) 2021: LEFT HIP.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11596182 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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