Mpact Double Mobility Shells 01.32.158MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030861000), received between Aug 18, 2017 and Oct 2, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Malposition of Device; Malposition of Device

  AT ABOUT 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED CUP FROM THE PRIMARY SURGERY. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20351521 ↗
• InjuryApr 4, 2024Positioning Problem; Positioning Problem

  MPACT DM CUP DISLOCATED FROM THE ACETABULAR WALL WHEN THE SURGEON TRIED TO DISENGAGE THE CUP IMPACTOR. THE SURGEON THINKS THAT THE DISLOCATION IS RELATED TO THE CUP IMPACTOR BECAUSE THE PLATE INTERFERED WITH THE ACETABULAR BONE SO THE UNSCREWING WAS DIFFICULT. THE OSTEOPHYTES WERE CAREFULLY REMOVED DURING ACETABULAR PREPARATION. THE SURGEON DROPPED DOUBLE MOBILITY BECAUSE OF THE RISK OF DISLOCATION AND IMPLANTED AN MPACT CUP 2-HOLES WITH 2 SCREWS. THE DISLOCATION AND THE NEED TO REAM THE ACETABULUM AGAIN CAUSED 2.5 HOURS OF DELAY.

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

  MAUDE report 19039946 ↗
• InjuryMar 24, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 9870914 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS (B)(6). 20 DAYS AFTER PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9811230 ↗
• InjuryApr 26, 2018Insufficient Device Problem Information

  REVISION DUE TO SIGNS OF INFECTION. THE PATHOGEN WILL NOT BE AVAILABLE. THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED A SPACER ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7463818 ↗
• InjuryMar 7, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF DISLOCATION. THE CAUSE OF DISLOCATION IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7319698 ↗
• MalfunctionAug 18, 2017Device Issue; Device Issue

  DURING SURGERY THE SURGEON TRIED TO IMPLANT A 58 DM CUP, THE CUP WOULD NOT SEAT PROPERLY. THE SURGEON USED A 2-HOLE CUP WITH SCREWS. THE SURGEON HAD DIFFICULTY IMPLANTING THE 2-HOLE CUP. WHEN THE SURGEON WENT TO IMPLANT A SIZE 3 STANDARD FEMUR, HE WAS UNABLE TO STABILIZE THE LEG. AT THIS TIME THE SURGEON WAS USING A FLAT LINER. THE SURGEON MOVED TO A LATERALIZED STEM AND A HOODED LINER TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON STATED HE COULDN'T GET A GOOD PRESS FIT WITH THE CUP. THE STEM WAS SWITCHED FOR STABILITY PURPOSES. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803634 ↗