BI-MENTUM PE Liner BI-MENTUM PE Liner 22,2 / 45Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03662200015511), received between May 25, 2021 and Dec 1, 2025 — classified as 29 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED HIP. REVISED CUP FOR STABILITY. RETAINED STEM. NO IMPLANT FAILURE. NO LOOSENING. ALL PIECES RETRIEVED. AFFECTED SIDE-LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23682529 ↗
• InjuryAug 1, 2025Migration; Migration

  PATIENT OCCURED AN INSTABILITY OF HIS HIP CONSTRUCT LEADING TO A REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 22686264 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ACETABULAR CUP, PINNACLE DM LINER, BI-MENTUM POLY LINER AND FEMORAL HEAD WERE REVISED FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22667286 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS HAVING TROUBLE WITH STABILITY/DISLOCATIONS DESPITE CORRECTLY POSITIONED IMPLANTS. SURGEON REMOVED DUAL MOBILITY CONSTRUCT AND PUT A CONSTRAINED CONSTRUCT IN. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22292351 ↗
• InjuryJun 11, 2025Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PATIENT OCCURRED TROUBLE WITH STABILITY/DISLOCATION OF HIS IMPLANTS ON HIS LEFT HIP. SURGEON REMOVED THE DUAL MOBILITY CONSTRUCT AND PUT A CONSTRAINED CONSTRUCT.

  Patient problems: Joint Dislocation

  MAUDE report 22184495 ↗
• InjuryJan 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): (B)(6) "PATIENT WAS REVISED DISLOCATING, CONVERTED THIS TO A CONSTRAINED LINER. IT WAS UNKNOWN ABOUT SURGICAL DELAY. "

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21230869 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): SERF (B)(6) PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21230740 ↗
• 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21230738 ↗
• 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 INFECTION. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21230581 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): (B)(6) IT WAS REPORTED THAT WASHOUT WAS DONE.

  Patient problems: Unspecified Infection

  MAUDE report 21229859 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): (B)(6) THE PATIENT WAS REVISED DUE TO DISLOCATION. NO SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226028 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): SERF 46-2023 PATIENT WAS REVISED WITH HIP DISLOCATION AND WAS OUT FOR A WEEK SO THE LEG WAS VARY CONTRACTED. SURGEON FIRST STARTED BY REMOVING DUAL MOBILITY AND PUTTING IN A CONSTRAINED LINER TRIED TO REDUCE A 32 +5 HEAD BUT WITH THE LEG BEING CONTRACTED, IT WAS UNABLE TO GET THE HIP REDUCED, THEN TRIED A 32 +1 HEAD AND AFTER MANY ATTEMPTS. SURGEON FINALLY REDUCED THE HIP BUT CRACKED THE TOP OF THE CONSTRAINED LINER, AFTER 30 MINUTES OF REMOVING THE CONSTRAINED LINER SURGEON WENT WITH A 36 +4 10* LINER AND 36 +8.5 HEAD.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226027 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): SERF RC-23-0080 PATIENT WAS REVISED DUE TO HIP DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21225999 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20786744 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19938933 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17603614 ↗
• InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO A DISLOCATION AND WAS CONVERTED TO A CONSTRAINED LINER. SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17597322 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASHOUT WAS DONE. DOI: UNKNOWN, DOR: (B)(6), 2023, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 17479397 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Dislocation

  MAUDE report 17442716 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17125956 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HIP DISLOCATION AND WAS OUT FOR A WEEK SO THE LEG WAS VARY CONTRACTED. SURGEON FIRST STARTED BY REMOVING DUAL MOBILITY AND PUTTING IN A CONSTRAINED LINER TRIED TO REDUCE A 32 +5 HEAD BUT WITH THE LEG BEING CONTRACTED, IT WAS UNABLE TO GET THE HIP REDUCED , THEN TRIED A 32 +1 HEAD AND AFTER MANY ATTEMPTS. SURGEON FINALLY REDUCED THE HIP BUT CRACKED THE TOP OF THE CONSTRAINED LINER, AFTER 30 MINUTES OF REMOVING THE CONSTRAINED LINER SURGEON WENT WITH A 36 +4 10* LINER AND 36 +8.5 HEAD. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16815097 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16693180 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE HIP. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15283702 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S GREATER TROCHANTER WAS BROKEN FROM A PRIOR OPERATION AND THE HIP HAD BECOME UNSTABLE AND DISLOCATED. SURGEON ELECTED TO PLACE A CONSTRAINED LINER. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15208865 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT CONVERTED FROM PINNACLE DM TO CONSTRAINED LINER, CHRONIC DISLOCATER. EXPLANTED DM LINER, PE LINER AND HEAD. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 14717815 ↗