BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 61Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03662200015719), received between Jun 17, 2020 and Jul 28, 2025 — classified as 6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT OCCCURED AN INFECTED HIP LEADING TO THE REVISION OF THE COMPETITOR FEMORAL HEAD. THE LINER REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22636878 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED HIP. THE FEMORAL HEAD WAS REMOVED AND REPLACED. ORIGINAL DATE OF SURGERY WAS UNKNOWN BUT MENTIONED (B)(6) 2024 AT AN UNKNOWN FACILITY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22522290 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): (B)(6) "PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. DELTA CERAMIC HEAD AND BI-MENTUM LINER WERE SWAPPED OUT DURING THE I&D WASHOUT. "

  Patient problems: Unspecified Infection

  MAUDE report 21230743 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. DELTA CERAMIC HEAD AND BI MENTION LINER WERE SWAPPED OUT DURING THE IRRIGATION AND DEBRIDEMENT (I&D). DOI: (B)(6), 2023, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17606828 ↗
• InjuryNov 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED HIS HIP. REVISION SURGERY WAS NEEDED TO REDUCE THE HIP AS WELL AS GO UP ON HEAD SIZE IN ORDER TO GAIN MORE STABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10853469 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD VERY HIGH HIP CENTER ON PRIMARY HIP PERFORMED IN (B)(6) OF 2019 AND AT THAT TIME PATIENT WAS LEFT SHORT. TODAY, A LONGER STEM WAS PLACED TO GET THE PATIENT BACK CLOSER TO EQUAL LEG LENGTHS. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10164295 ↗