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
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
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page