Mpact Acetabular System 01.32.3241HCATRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030811869), received between Jul 25, 2018 and Jan 15, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21158831 ↗
• InjuryJun 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM WAS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, LINER AND COMPETHITOR HEAD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17216772 ↗
• InjuryDec 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HOODED LINER WITH A FACE CHANGING LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. AN AMIS APPROACH WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 15987212 ↗
• InjuryJan 19, 2022Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT OCCURRED WHEN THE PATIENT WAS GETTING UP FROM A SEATED POSITION. AT 2 MONTHS FROM REVISION THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13289791 ↗
• InjuryJul 6, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S CUP AND LINER 2 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. A POSTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 10232763 ↗
• InjuryDec 13, 2019Unstable; Device Dislodged or Dislocated

  1 YEAR AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF PAIN DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON DETERMINED THAT THE PATIENT WAS NOT STABLE. THE SURGEON REVISED THE HEAD AND LINER AND INCREASED THE THICKNESS TO CREATE MORE STABILITY FOR THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 9464965 ↗
• InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY-SWAP 1 MONTH AND 5 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9222731 ↗
• InjuryJul 25, 2018Device Dislodged or Dislocated

  ON (B)(6) 2018 WE WERE INFORMED THAT PATIENT IS DISLOCATING ANTERIORLY, THE HEAD DISLOCATED FROM THE LINER. SURGEON IS GOING TO CHANGE THE LINER ORIENTATION AND THE HEAD OFFSET. É REVISION SURGERY PERFORMED ON (B)(6) 2018. REVISION SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7718453 ↗