BI-MENTUM PE Liner BI-MENTUM PE Liner 22,2 / 41Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03662200015498), received between Mar 24, 2021 and Jan 24, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

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

  (B)(4): SERF RC-23-0087 PATIENT WAS REVISED DUE TO INFECTION AND REMOVAL OF DUAL MOBILITY HEAD TO WASH OUT.

  Patient problems: Unspecified Infection

  MAUDE report 21230584 ↗
• 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 PAIN.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21230318 ↗
• 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 PAIN.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21230151 ↗
• InjuryJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(4): (B)(6) PROCEDURE - PRIMARY TOTAL HIP REPLACEMENT LINER CATALOG NUMBER - DS10014122 LINER LOT NUMBER -1907174A PRIMARY DX - AVASCULAR NECROSIS REPORTED AE -DISLOCATION AND SUBLUXATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 21226026 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4): (B)(6): THIS PI IS COVERING INFECTION. NOTES: FROM (B)(4) AEI NOTE (B)(6) MEDICAL RECORDS (B)(6) 2023 PERTAINING TO NON-MOM CONSTRUCT WAS REVIEWED BY CLINICIAN. ON (B)(6) 2022, THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED. PART/LOT PAGE 6 OF 632 (B)(4). MEDICAL RECORDS (B)(6) 2023.PDF). ON (B)(6) 2022, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY (PAGE 615 OF 632 NO SPECIFICS). ON (B)(6) 2023, THE PATIENT HAD A RIGHT HIP REVISION OF ACETABULAR LINER AND FEMORAL HEAD TO ADDRESS CATASTROPHIC FAILURE. INDICATIONS FOR SURGERY INCLUDED PATIENT HAVING PAIN, MULTIPLE FALLS, AND A RADIOGRAPH DEMONSTRATED FEMORAL HEAD HIGH IN THE CUP, WHICH IS CONSISTENT WITH CATASTROPHIC FAILURE OR LINER DISLOCATION (DISASSOCIATION). DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE LINER HAD COME LOOSE AND HAD ROTATED INTO AN INFERIOR POSITION RESULTING IN ARTICULATION AND IMPINGEMENT OF THE CERAMIC HEAD. THE FEMORAL HEAD HAD A SIGNIFICANT STRIPE WEAR CONSISTENT WITH METAL WEAR. THE CUP AND STEM WERE RETAINED. DEPUY PINNACLE DUAL MOBILITY LINER, DEPUY BI-MENTUM PE LINER AND DEPUY ARTICUL/EZE FEMORAL HEAD WERE IMPLANTED DURING THIS PRO

  Patient problems: Unspecified Infection

  MAUDE report 21226001 ↗
• InjuryDec 3, 2024Unstable; Unstable

  PATIENT WAS REVISED DUE TO IMPINGEMENT. PATIENT CONSEQUENCES: JOINT INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 20829968 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO IMPINGEMENT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19972809 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD (B)(6) 2023 PERTAINING TO NON MOM CONSTRUCT WAS REVIEWED BY CLINICIAN. (B)(6) 2023 MRI DEMONSTRATES RIGHT HIP ARTHROPLASTY, MILD INCREASED SIGNAL ON FLUID SENSITIVE SEQUENCES ALONG THE FEMORAL STEM. MODERATE RIGHT GREATER TROCHANTERIC BURSITIS VERSUS HEMATOMA/SEROMA. THE PATIENT ALSO REPORTED HAVING WEAKNESS AND PAIN. THE IMPRESSION IS MILD TROCHANTERIC BURSITIS. ILIOPSOAS TENDINITIS APPEARS TO BE FROM PROMINENCE OF THE IRRITATING PSOAS TENDON ITSELF. CORTICOSTEROID INJECTION IS RECOMMENDED. DOI: (B)(6) 2022 ( STEM). DOI: (B)(6) 2023 (LINER, HEAD). DOE: (B)(6) 2023. RIGHT HIP.

  Patient problems: Fatigue; Hematoma; Inflammation; Muscle/Tendon Damage; Pain; Seroma; Swelling/ Edema

  MAUDE report 18442516 ↗
• InjurySep 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EARLY STAGE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023 AND DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17805295 ↗
• InjuryAug 24, 2023Adverse 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) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17610288 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17389468 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND REMOVAL OF DUAL MOBILITY HEAD TO WASH OUT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17198486 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRIMARY TOTAL HIP REPLACEMENT INCURRED A DISLOCATION AND SUBLUXATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17197952 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17171081 ↗
• InjuryJul 7, 2022Adverse 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: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14944606 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14653560 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13928065 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOOSENING WAS FROM INFECTION. THIS WAS CONSIDERED TO BE STAGE TWO REVISION. PROSTALIC WAS IMPLANTED FOR CONTINUUM CARE. THE CASE IN JUNE WAS AN IRRIGATION AND DEBRIDEMENT AND CONVERTED TO A DUAL MOBILITY. SURGERY TIME WAS EXTENDED TO REMOVE THE IMPLANTS AND ALSO TO IRRIGATE AND DEBRIDE THE TISSUES AND ALLOWING FOR MOLD TO CURE.

  Patient problems: Unspecified Infection

  MAUDE report 13051065 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED AN INFECTION FOR THE SECOND TIME. THE LINER AND HEAD WAS REMOVED AND REPLACED. THE PATIENT WAS I&D AND CULTURES WERE DONE. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12094728 ↗
• InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED DURING A PHYSICAL THERAPY SESSION. WAS BROUGHT TO OR FOR OPEN REDUCTION. HEAD AND LINER WERE EXCHANGED TO LENGTHEN THE HIP SLIGHTLY DUE TO LEG LENGTH DISCREPANCY NOTED BY THE PATIENT BUT WAS INTENTIONALLY LEFT SHORT AFTER MULTIPLE SURGERIES DUE TO CONTRACTION OF SOFT TISSUES. DOI: (B)(6) 2021 DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Physical Asymmetry

  MAUDE report 12083462 ↗
• InjuryMar 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT DISLOCATED THEIR HIP MULTIPLE TIMES DUE TO INADEQUATE ABDUCTORS. PINNACLE DM LINER WAS REMOVED AND REPLACED WITH A CONSTRAINED LINER. ZIMMER BIOMET STEM WAS RETAINED SO THEIR 28MM HEAD WAS USED. DOI: (B)(6) 2021. DOR: (B)(6) 2021; (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 11561155 ↗