Mpact Acetabular System 01.32.156MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030810862), received between Jun 14, 2019 and Feb 6, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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.

• InjuryFeb 6, 2025Osseointegration Problem; Unintended Movement; Osseointegration Problem; Unintended Movement

  THE PATIENT CAME IN REPORTING PAIN DUE TO THE CUP TEARING THROUGH THE ACETABULUM DUE TO POOR BONE. THE SURGEON REVISED THE STEM AND HEAD WITH MEDACTA COMPONENTS AND REVISED THE CUP AND LINER TO COMPETITOR COMPONENTS AT ABOUT 1 YEAR AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. FROM THE ANALYSIS OF THE X-RAYS, IT WAS DISCOVERED ALSO THE LOOSENING OF THE STEM.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 21321318 ↗
• InjurySep 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A BROKEN ACETABULAR BONE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20133228 ↗
• InjuryJun 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE PATIENT HAD A MALPOSITIONED CUP AND THE CAUSE OF THE MALPOSITIONED CUP IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 17134718 ↗
• InjuryJun 1, 2023Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  REVISION SURGERY FOR SHELL LOOSENING, ABOUT 9 MONTHS POST-PRIMARY. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17036587 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AND A HALF AFTER PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13631290 ↗
• InjuryFeb 21, 2022Appropriate 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, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13567346 ↗
• InjuryMar 15, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 6 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11481913 ↗
• InjuryMar 10, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN 2 YEARS 4 MONTHS AFTER THE PRIMARY AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER AND ADDED A SLEEVE. NO OSTEOINTEGRATION WAS FOUND ON THE CUP UPON ITS REMOVAL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11451536 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10301337 ↗
• InjuryJun 14, 2019Fitting Problem

  THE SURGEON WAS NOT ABLE TO FIX A 56MM MPACT CUP IN THE PATIENT'S ACETABULUM. HE PERFORMED AN ADDITIONAL REAMING AND REPLACED THE CUP WITH A NEW 58MM MPACT CUP, BUT HE WAS NOT ABLE TO FIX IT AGAIN, 5 MPACT SCREWS HAVE BEEN THEN USED. AFTER THAT, HE TRIED TO ENGAGE A FLAT LINER, BUT HE WAS NOT ABLE. HE REPLACED THE FLAT LINER WITH A NEW HOODED LINER BUT HE WAS NOT ABLE AGAIN. AFTER THE CONFIRMATION THAT THERE WERE NOT OBSTACLES BETWEEN CUP AND LINER, HE TRIED AGAIN TO ENGAGE THE FLAT LINER CHANGING THE DIRECTION OF THE IMPACTION AND APPLYING A STRONGER FORCE. THE FLAT LINER SEEMED TO BE NOT COMPLETELY ENGAGED, THE SURGEON CONFIRMED THE FLAT LINER DID NOT DISENGAGE BY HAND AND COMPLETED THE SURGERY. AFTER THE SURGERY, THE SURGEON TRIED TO ENGAGE THE 56MM MPACT CUP WITH THE HOODED LINER, OUTSIDE THE PATIENT, AND HE WAS ABLE TO COUPLE THEM.

  Patient problems: No Code Available

  MAUDE report 8699597 ↗