Mpact Acetabular System 01.32.146MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030810718), received between Jun 28, 2019 and Sep 15, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 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.

• InjurySep 15, 2021Loose or Intermittent Connection

  THE PRIMARY SURGERY PERFORMED ON (B)(6) 2020. THE PATIENT CAME TO THE HOSPITAL (B)(6) 2021 AND THE SURGEON NOTICED LOOSENING OF CUP AND STEM. THE REVISION SURGERY PERFORMED ON (B)(6) 11 MONTHS AFTER THE PRIMARY SURGERY. THE REASON WHICH OCCURRED GAP AND/OR LOOSENING AT ACETABULAR SIDE IS NOT CLEAR.

  Patient problems: Insufficient Information

  MAUDE report 12475428 ↗
• MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation

  THE SURGEON DISCOVERED DEBRIS OF THE COATING IN THE INNER BLISTER BEFORE IMPLANTING THE MPACT CUP. IT WAS DOUBTFUL IF THEY WERE GENERATED FROM TITANIUM COATING, SO IN ORDER TO AVOID ANY RISK, A BACK UP MPACT CUP 48MM WAS USED FOR THE ALTERNATIVE. NO CRITICAL DELAY. NO PATIENT RELATED THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743235 ↗