BI-MENTUM PE LinerRecalls & reported problems across all models
Soc Etudes Recherches Fabrication · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 186
- Deaths reported
- 0
- Injuries reported
- 186
- Recalls
- 0
We found 11 models of BI-MENTUM PE Liner by Soc Etudes Recherches Fabrication in the FDA's device registry (GUDID). Together they are named in 186 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2020 and Aug 7, 2026 — classified as 186 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BI-MENTUM PE Liner problems
Device problems
- Adverse Event Without Identified Device or Use Problem130
- Device Dislodged or Dislocated40
- Appropriate Device Problem Term/Code Not Available12
- Insufficient Device Problem Information11
- Unstable2
- Loose or Intermittent Connection1
- Mechanical Problem1
- Migration1
Patient problems
- Joint Dislocation72
- Unspecified Infection62
- Pain34
- Joint Laxity20
- Ambulation or Postural Difficulties14
- Insufficient Information13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Fall5
BI-MENTUM PE Liner models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 49Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate39 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 47Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented38 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 22,2 / 43Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented31 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 22,2 / 45Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate29 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 22,2 / 41Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate21 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 51Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate9 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 61Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate6 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 55Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 57Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate1 report
- BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 59Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Recent BI-MENTUM PE Liner adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24558274 ↗InjuryMar 4, 2026Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2025 . DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24511329 ↗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, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT OCCURED A REVISION OF THE PE LINER DUE TO DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 23726519 ↗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 ↗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 ↗InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23633940 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 ↗InjuryAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT OCCURED A HIP LUXATION 3 WEEKS AFTER SURGERY.
Patient problems: Joint Dislocation
MAUDE report 22686961 ↗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 ↗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 ↗
Other Soc Etudes Recherches Fabrication products
All Soc Etudes Recherches Fabrication devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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