Mpact Acetabular System 01.32.3648HCATRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030812125), received between Feb 16, 2018 and Apr 6, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2022Device Dislodged or Dislocated

  AT 2 DAYS AFTER THE PRIMARY LEFT HIP SURGERY, THE PATIENT'S HEAD DISLOCATED FROM THE LINER IN PHYSICAL THERAPY. THE SURGEON CONVERTED THE PATIENT TO A DM HEAD AND LINER, REVISED THE STEM, AND REPOSITIONED THE CUP AND ADDED 2 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 14019141 ↗
• InjuryAug 9, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  ON THE SAME DAY OF THE PRIMARY SURGERY, IT WAS OBSERVED THAT THE PATIENT WAS IN PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD M WITH A 40MM BIOLOX DELTA HEAD M AND REVISED THE MPACT HOODED LINER HC 36/F WITH A MPACT FLAT LINER HC 40/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 8878378 ↗
• InjuryFeb 16, 2018Contamination

  REVISION SURGERY DUE TO SIGNS OF INFECTION 1 YEAR AND 9 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 7276637 ↗
• InjuryFeb 16, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER PRIMARY. THE PATHOGEN WILL NOT BECOME AVAILABLE. THE SURGEON WASHED OUT THE HIP AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7276209 ↗