Mpact Acetabular System 01.32.3644HCATRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030812101), received between Jan 12, 2018 and Nov 28, 2025 — classified as 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT HAD PRIMARY HIP SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETIITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY (B)(4). ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER TO PROVIDE MORE OFFSET. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23669512 ↗
• InjuryApr 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION, FEW DAYS AFTER THE PRIMARY SURGERY AND CLOSE REDUCTION. THE HIP WAS UNSTABLE ALSO DURING REVISION SURGERY AND LED TO SURGEON DECISION TO REVISE ALL COMPONENTS.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19173866 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 18139705 ↗
• InjuryDec 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE HEAD AND LINER.

  Patient problems: Medical device site infection

  MAUDE report 16004172 ↗
• InjuryApr 20, 2022Appropriate Device Problem Term/Code Not Available

  AT 3 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN PATIENT DUE TO PSOAS MUSCLE IRRITATION AND THE CAUSE OF THIS IRRITATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14157897 ↗
• InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 12974380 ↗
• InjuryApr 26, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11723874 ↗
• InjuryDec 13, 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 A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9464962 ↗
• InjuryJan 9, 2019Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2017 AND SUBSEQUENTLY DISLOCATED. ON (B)(6) 2018, THE LINER WAS REVISED WITH A MEDACTA LINER AND THE HEAD WAS REVISED WITH ANOTHER COMPANY'S HEAD . PRESENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE COMPETITOR'S HEAD WITH ANOTHER COMPANY'S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. A POSTERIOR APPROACH WAS USED IN PRIMARY SURGERY.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 8230874 ↗
• InjuryJan 12, 2018Unstable

  THE PATIENT COMPLAINED HIP INSTABILITY. THE SURGEON REVISED THE PATIENT SWAPPING SUCCESSFULLY THE LINER.

  Patient problems: Joint Disorder

  MAUDE report 7185481 ↗