BI-MENTUM PE Liner BI-MENTUM PE Liner 28 / 53Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03662200015672), received between Sep 9, 2020 and Mar 23, 2026 — 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 24661505 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA (B)(4): PATIENT WAS REVISED FOR INFECTED HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20756001 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTED HIP. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20524218 ↗
• InjurySep 11, 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 INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20191794 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17491583 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: DOE: (B)(6) 2022: PATIENT PRESENTS WITH PAIN AND FEELINGS OF INSTABILITY IN HER LEFT HIP. X RAYS IDENTIFY A WELL-FIXED AND STABLE THA. PATIENT IS TREATED WITH PHYSICAL THERAPY AND ORAL MEDICATION. DOE: (B)(6) 2022: PATIENT RECEIVED A CLOSED REDUCTION OF THE LEFT HIP TO TREAT A DISLOCATION AFTER A SLIP AND FALL WHILE FEEDING HER CAT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT IS PRESCRIBED ADDITIONAL PHYSICAL THERAPY. PATIENT CONTINUED TO EXPERIENCE PAIN AND INSTABILITY AFTER PHYSICAL THERAPY AND ON (B)(6) 2023, THE PATIENT WAS REFERRED FOR REVISION TO TREAT THE INSTABILITY AND PAIN SECONDARY TO DISLOCATION OF THE LEFT HIP FOLLOWING A FALL. (B)(6) 2023: PATIENT RECEIVED A LEFT HIP REVISION TO TREAT INSTABILITY AND PAIN SECONDARY TO A DISLOCATION AFTER A FALL. THE FEMORAL STEM WAS STABLE AND RETAINED. THE CUP, SCREWS, AND DUAL MOBILITY HEAD/LINER WERE REVISED AND REPLACED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE DISLOCATION TREATED WITH CLOSED REDUCTION AND THE REVISION TO TREAT INSTABILITY ARE CONTINUATIONS OF THE SAME EVENT. DOI: (B)(6) 2023 DOE: (B)(6) 2022 DOR: (B)(6) 2023 LEFT HIP.

  Patient problems: Fall; Fatigue; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 17323975 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13002059 ↗
• InjuryMay 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS WOUND BREAKDOWN WITH HEMATOMA AND DRAINAGE, RECURRENT INSTABILITY WITH DISLOCATION, AND COAGULOPATHY. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A REVISION 6 WEEKS PRIOR (CAPTURED IN PC-(B)(4)) TO ADDRESS A FAILED CONSTRAINED LINER AND MEDICAL RECORDS INDICATED THE PATIENT WAS HAVING PAIN.. THE PATIENT DISLOCATED AFTER THAT SURGERY AND NEEDED A REDUCTION. DURING THIS CURRENT PROCEDURE THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE SURGEON REPORTED FINDING A COMPLETE FAILURE OF THE POSTERIOR SOFT TISSUE, AND REALLY NO LONGER ANY SOFT TISSUES PRESENT TO REPAIR. THERE WAS A SMALL AMOUNT OF HEMATOMA. HE WAS COAGULOPATHIC DURING THE CASE.

  Patient problems: Fluid Discharge; Hematoma; Joint Dislocation; Joint Laxity; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11871929 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020 DOR: (B)(6) 2020 RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10507830 ↗