Mpact Acetabular System 01.32.150SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030810787), received between Mar 4, 2021 and Mar 30, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2022Appropriate Device Problem Term/Code Not Available

  AT 4 MONTHS FROM PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13947487 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO SOFT TISSUE HEALING ISSUES (OBESE PATIENT). THE SURGEON REVISED THE LINER AND THE FEMORAL HEAD. THE SWABS WERE SENT TO A LABORATORY FOR INFECTION, IN ORDER TO CHECK IF ANY BACTERIA ARE PRESENT(RESULTS WILL BE AVAILABLE LATER). IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE.

  Patient problems: Impaired Healing

  MAUDE report 12216034 ↗
• InjuryJul 13, 2021Malposition of Device; Malposition of Device

  REVISION SURGERY 1 YEAR AFTER PRIMARY BECAUSE THE CUP WAS TOO CRANIAL AND MEDIALIZED. CUP, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12157188 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem

  1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING GROIN PAIN, WHICH WAS CAUSED BY OVER ANTEVERTED CUP POSITION. THE CAUSE OF THE ANTEVERTED CUP IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11938617 ↗
• InjuryMar 4, 2021Malposition of Device; Malposition of Device

  THE PATIENT CAME IN 9 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO CUP IMPINGEMENT WITH THE SOFT TISSUE. THE CUP WAS IN A SUBOPTIMAL POSITION SINCE THE PRIMARY SURGERY. THE SURGEON REVISED THE CUP, HEAD AND LINER AND ADDED A SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ONLY REASON THE HEAD WAS REVISED IS BECAUSE IT NEEDED TO BE DOWNSIZED TO FIT DUAL MOBILITY.

  Patient problems: Pain

  MAUDE report 11411809 ↗