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Mpact Double Mobility Shells 01.32.160MBRecalls & reported problems

Medacta International SA · Double Mobility Acetabular shell Ø60 · Class 2 · Implant

All models of Mpact Double Mobility Shells (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030861017), received between Jun 26, 2019 and Oct 20, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available2
  • Loose or Intermittent Connection1

Patient problems

  • Unspecified Infection4
  • Failure of Implant1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Unspecified Infection

    MAUDE report 10703209 ↗
  • InjuryMar 12, 2020Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 18 DAYS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9826672 ↗
  • InjuryMar 12, 2020Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AFTER ALMOST 1 MONTH FROM THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9826671 ↗
  • InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 10 MONTHS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE MEDACTA VERSAFITCUP DM LINER HC 60/28 AND MEDACTA MPACT DM ACETABULAR SHELL AND INSERTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9191667 ↗
  • InjuryJun 26, 2019Loose or Intermittent Connection

    DURING THE PRIMARY HIP SURGERY AND AFTER IMPLANTING THE DM CUP, THE SURGEON OBSERVED THAT THE CUP WAS LOOSE. THE SURGEON REMOVED THE CUP, AND IMPLANTED A SLURRY BONE GRAFT AND REIMPLANTED THE CUP, BUT THE CUP WAS STILL LOOSE. THE SURGEON CHOSE TO IMPLANT A MULTI HOLE CUP WITH SCREWS AND THE SURGEON STATED IT WAS WELL FIXATED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Failure of Implant

    MAUDE report 8734042 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices →

Sources and updates

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