BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 49Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 03662200015658), received between Dec 10, 2020 and Dec 5, 2025 — classified as 39 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 39 reports, in the reporter's own words as published by the FDA.

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

  (B)(4): SERF RC-23-0136 "PATIENT WAS REVISED DUE TO EARLY INFECTION. HEAD LINER EXCHANGED. NO ADDITIONAL INFORMATION IS AVAILABLE."

  Patient problems: Unspecified Infection

  MAUDE report 21230744 ↗
• 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): SERF 05-2023 PATIENT WAS REVISED DUE TO HIP JOINT INFECTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21230597 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): SERF RC-24-0323 IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING WAS THERE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21230158 ↗
• 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): SERF 06-2023 IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21229480 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  (B)((4): (B)(6) IT WAS REPORTED THAT THE PATIENT HAD A HIP DISLOCATION. THE STEM, DUAL MOBILITY LINER & HEAD WERE REVISED. RECLAIM & PINNACLE CONSTRAINED LINER WERE IMPLANTED. NO SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226111 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  (B)(4): PATIENT WAS REVISED DUE TO LEFT HIP DISLOCATION. THE EXPLANTED IMPLANTS WERE ARTICULATING WITH A HIP RESURFACING CUP THAT WAS DONE IN INDIA. DATE UNKNOWN. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21225990 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 19761361 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19125806 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18276992 ↗
• InjurySep 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DATE OF IMPLANT: (B)(6) 2022, DATE OF REVISION: (B)(6) 2023, (LEFT HIP). TREATMENT: HEAD AND LINER WERE REVISED. REVISION DUE TO DISLOCATION. THE TWO ARTICULATING SURFACES ARE THE PINNACLE DM LINER AND BIMENTUM LINER, WHICH HAVE BEEN REPORTED FOR THE DISLOCATION. IT IS REASONABLE TO CONCLUDE THE REVISED FEMORAL HEAD DID NOT CAUSE OR CONTRIBUTE TO THE DISLOCATION AS IT IS ENCLOSED WITHIN THE BIMENTUM LINER AND DOES NOT INTERACT WITH THE ARTICULATING SURFACES.

  Patient problems: Joint Dislocation

  MAUDE report 17797556 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EARLY INFECTION. HEAD LINER EXCHANGED. DOI- (B)(6) 2023, DOR- (B)(6) 2023, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17603620 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DISLOCATION. THE STEM, DUAL MOBILITY LINER & HEAD WERE REVISED. RECLAIM & PINNACLE CONSTRAINED LINER WERE IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR:(B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16875923 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEFT HIP DISLOCATION. THE EXPLANTED IMPLANTS WERE ARTICULATING WITH A HIP RESURFACING CUP THAT WAS DONE IN INDIA. DATE UNKNOWN. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021 . DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16263410 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16239595 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP JOINT INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 16226139 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN/DISCOMFORT. SURGEON REMOVED THE DUAL MOBILITY LINER AND STEM TO SHORTEN THE OFFSET OF THE LIMB. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE- LEFT HIP.

  Patient problems: Discomfort; Pain; Physical Asymmetry

  MAUDE report 15748745 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 15713853 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFECTED HIP WAS WASHED OUT AND DEBRIDED. HEAD AND LINER WERE EXCHANGED FOR NEW COMPONENTS. THERE WERE NO DEFICIENCIES NOTED WITH COMPONENTS. EXPLANTED COMPONENTS ARE NOT AVAILABLE FOR RETURN. LOT NUMBERS WERE NOT LEGIBLE ON CERAMIC HEAD AND BIMENTUM HEAD. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14498858 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 14304011 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. RESECTION ARTHROPLASTY AND GIRDLE STONE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14209869 ↗
• InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED DUE TO INFECTED TOTAL HIP. HEAD AND LINER WAS EXCHANGED FOR IRRIGATION AND DEBRIDEMENT. BIMENTUM LINER WITH STRYKER HEAD WAS REMOVED AND REPLACED WITH A NEW CONSTRUCT DUE TO THE PRESENCE OF INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14084403 ↗
• InjuryMar 29, 2022Mechanical Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. A CONSTRAINED LINER DISLOCATED AND REVISED TO THE DUAL MOBILITY ON (B)(6) 2021. SHE DISLOCATED 2 WEEKS POST OP THE FIRST TIME. SHE WAS OK UNTIL SHE HAD A GYNECOLOGICAL PROCEDURE DONE A FEW WEEKS AGO, THEN HER HIP HURT AND DISLOCATED AGAIN ON (B)(6) 2022 WHILE TRYING TO GET UP FROM SITTING IN A CHAIR. SHE WAS REVISED TO ANOTHER CONSTRAINED LINER THIS TIME. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13938282 ↗
• InjuryMar 10, 2022Appropriate Device Problem Term/Code Not Available

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13721305 ↗