Mpact Double Mobility Shells 01.32.146MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030860942), received between May 15, 2019 and Jan 20, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE ACETABULUM (LINER FROM CUP) AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE CUP WAS WELL FIXED IN THE ACETABULUM AND THE DISLOCATION WAS BETWEEN THE LINER AND THE SHELL. THE SURGEON REVISED THE CUP, LINER, AND HEAD 2 MONTHS AFTER THE PRIMARY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 11200972 ↗
• MalfunctionMay 15, 2019Device Contamination with Chemical or Other Material

  DURING THE PRIMARY HIP SURGERY AND UPON OPENING THE STERILE PACKAGING OF THE 46MM CUP, IT WAS DISCOVERED THAT THERE WAS FOREIGN DEBRIS ON THE CUP (PIECE OF COATING). THE SURGEON IMPLANTED A DIFFERENT 46MM CUP AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT STATED THE CUP CAME OUT OF A CONSIGNMENT SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612049 ↗