Mpact Double Mobility Shells 01.32.156MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030860997), received between Jul 21, 2017 and Oct 23, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 23, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD HIP INSTABILITY AND THE CAUSE WAS UNKNOWN. AT ABOUT 5 YEARS AND 1 MONTH POST PRIMARY UPON OPENING THE PATIENT, IT WAS OBSERVED THAT THE CUP WAS LOOSE AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 20512683 ↗
• InjuryJun 12, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 4 YEARS AND 4 MONTHS POST PRIMARY REVISION SURGERY FOR MPACT DM LOOSENING. ACETABULAR COMPONENTS AND HEAD WERE REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19517427 ↗
• InjurySep 19, 2023Malposition of Device; Malposition of Device

  AT ABOUT 1 YEAR AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN ANTEVERTED CUP 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: Pain

  MAUDE report 17773622 ↗
• InjuryJul 7, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA CUP, LINER AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17276824 ↗
• InjuryAug 27, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE ACETABULAR SHELL WAS NOT WELL FIXED WITHIN THE ACETABULUM. THE SURGEON DECIDED TO REVISE THE PATIENT AND REVISED THE SHELL, LINER, AND FEMORAL CERAMIC HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10458657 ↗
• InjuryOct 31, 2019Positioning Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN, AND THE CAUSE OF THE PAIN WAS A DISLOCATION. POST-OP X-RAYS INDICATED THAT THE CUP WAS PLACED TOO LATERAL WHICH CAUSED A DISLOCATION. THE SURGEON REVISED THE CUP 1 DAY AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9260078 ↗
• InjuryJun 14, 2019Device Slipped

  REVISION SURGERY PERFORMED AFTER 1,5 MONTH DUE TO PAIN CAUSED BY A LOOSE CUP. THE SURGEON REVISED THE 56MM MPACT DM CUP WITH A 58MM MPACT TWO HOLE CUP AND ALSO REVISED THE HEAD AND LINER. TE PATIENT WAS DIABETIC. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8699599 ↗
• InjuryJul 21, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED FOR INFECTION. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6731941 ↗