BI-MENTUM Cemented Cup BI-MENTUM Cemented Cup 43Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662200015382), received between Aug 3, 2021 and Oct 12, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 15587744 ↗
• InjuryAug 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION UPDATE RECEIVED WHICH INDICATES THAT THE HIP HAS NOW BEEN REVISED TO ADDRESS THE DISLOCATION ADVERSE EVENT. THE HIP REVISION OCCURRED ON (B)(6) 2021, AND THE REVISION LOG ENTRY REPORTED THAT THE BIMENTUM CONSTRUCT LINER ASSEMBLY (2 COMPONENTS BI MENTUM PFRK CEM CUP 43 AND BI MENTUM PFRK PE LINER 22 43), AND THE COMPETITOR FEMORAL HEAD AND STEM PROXIMAL BODY COMPONENTS, WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 12267052 ↗