BI-MENTUM PE Liner BI-MENTUM PE Liner 22,2 / 43Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03662200015504), received between Mar 31, 2021 and Mar 10, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 31 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: MEDICAL RECORDS RECEIVED. THE PATIENT PREVIOUSLY UNDERWENT A PRIMARY HIP REPLACEMENT THAT USED A METAL-ON-METAL IMPLANT. OVER TIME, FRICTION BETWEEN THE METAL COMPONENTS CAUSED THE RELEASE OF MICROSCOPIC METAL DEBRIS INTO THE SURROUNDING TISSUES. THIS LED TO THE DEVELOPMENT OF METALLOSIS, AN INFLAMMATORY REACTION TO METAL PARTICLES. THE RESULTING INFLAMMATION PRODUCED A MASS IN THE HIP REGION THAT APPEARED SIMILAR TO A TUMOR ON IMAGING STUDIES, PROMPTING AN EVALUATION FOR POSSIBLE CANCER. FURTHER INVESTIGATION REVEALED THAT THE MASS WAS ACTUALLY A PSEUDOTUMOR¿AN INFLAMMATORY, NON-CANCEROUS GROWTH CAUSED BY THE METAL DEBRIS FROM THE IMPLANT. ADDITIONAL DIAGNOSES AND CONDITION EXPERIENCED FOUND, INFLAMED AND IRRITATED JOINT LINING, WEAR-AND-TEAR CHANGES, EVIDENCE OF OLD JOINT BLEEDING, SOME BONE AREAS WITH CELL DEATH (OSTEONECROSIS), A REMOVED PROSTHETIC JOINT COMPONENT, VESICULAR PALMOPLANTAR ECZEMA, IMPETIGO, SEBACEOUS CYST, TROCHANTERIC BURSITIS, COLITIS, MECHANICAL COMPLICATION OF PROSTHETIC JOINT IMPLANT, AND MECHANICAL COMPLICATION OF PROSTHETIC HIP IMPLANT. MRI ON (B)(6) 2024 SHOWS FINDINGS MOST SUGGESTIVE OF LEFT HIP SYNOVITIS, WITH A FLUID COLLECTI

  Patient problems: Colitis; Cyst(s); Distress; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; Pain; Skin Inflammation/ Irritation; Swelling/ Edema; Synovitis

  MAUDE report 22330813 ↗
• InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT OCCURED CHRONIC DISLOCATIONS LEADING TO REVISION OF THE IMPLANTS.

  Patient problems: Joint Dislocation

  MAUDE report 22184496 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22143487 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): SERF RC-23-0092 PATIENT WAS REVISED DUE TO PAIN, SERROMA. THERE WAS NO LOOSENING REPORTED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21230149 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  (B)(4): SERF 02-2023 PATIENT WAS REVISED DUE DISLOCATING. NO LOOSENING AND SURGICAL DELAY WAS THERE.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226098 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  (B)(4): (B)(6) - PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21225974 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): SERF RC-23-0112, PATIENT WAS REVISED DUE TO DISLOCATION WITH DM WENT BACK IN WITH DIFFERENT LINER AND LONGER HEAD BALL.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21225775 ↗
• InjuryJan 8, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  PATIENT WAS CONTINUING TO DISLOCATE. THE LINER WAS CONVERTED FROM A DUAL MOBILITY TO A CONSTRAINED LINER. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21100501 ↗
• InjuryJan 6, 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. THE LINER WAS CONVERTED FROM A DUAL MOBILITY TO A CONSTRAINED LINER. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21079596 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION WITH DM WENT BACK IN WITH DIFFERENT LINER AND LONGER HEAD BALL. DOI: UNKNOWN, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17479223 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND SEROMA. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Seroma

  MAUDE report 17267113 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16149945 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SEEMS TO BE INFECTED. WASHED OUT HIP AND REPLACED DUAL MOBILITY HEAD WITH SAME SIZE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16137423 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE DISLOCATING. NO LOOSENING AND SURGICAL DELAY WAS THERE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16137047 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D OF HIP. LINER AND HEAD EXCHANGED. INFECTION WAS CONFIRMED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15979193 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 15587738 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15182583 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON REMOVED CUP, HEAD, AND LINER AND REPLACED WITH STRYKER DUAL MOBILITY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14685573 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION OF IMPLANTS. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14684792 ↗
• InjuryMay 12, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Pain

  MAUDE report 14372587 ↗
• InjuryMay 11, 2022Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14353123 ↗
• InjuryApr 6, 2022Appropriate Device Problem Term/Code Not Available

  IT WAS REVISED TO ADDRESS WASH OUT (INFECTED). DOI- UNKNOWN, DOR- (B)(6) 2022, AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14021658 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO JOINT INSTABILITY. THE MDM CONSTRUCT WAS REVISED WITH PINNACLE CONSTRAINED. DOI: UNKNOWN. DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13388731 ↗