Mpact Acetabular System 01.32.162DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030810978), received between Jul 30, 2018 and Oct 7, 2020 — classified as 1 injury, 2 malfunctions.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2020Malposition of Device; Malposition of Device

  THE PATIENT HIP HAS DISLOCATED (HEAD FROM LINER) TWICE SINCE THE PRIMARY SURGERY ON (B)(6) 2020, BOTH TIMES WHILST THE SURGEON WAS ON HOLIDAY. THE PATIENT NEEDED AN URGENT REVISION ONCE HE CONSULTED HIM ON HIS RETURN. THE STEM WAS REMOVED AND REPLACED WITH A COMPETITOR STEM. THE CUP WAS SALVAGED. THE CUP INTRODUCER WAS ENGAGED IN THE CUP AND THE ANTEVERSION MANUALLY DECREASED. NEW 20-DEGREE LINER IMPLANTED. PATIENT APPEARED MORE STABLE. DURING PRIMARY: VALGUS STEM PLACEMENT, ANTE VERSION ON BOTH STEM AND CUP AND INCORRECT CHOICE OF OFFSET STEM AND HEAD, CONTRIBUTED TO AN INADEQUATE HIP OFFSET AND SUCCESSIVE DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 10640899 ↗
• MalfunctionJan 2, 2019Loose or Intermittent Connection

  DURING THE PRIMARY HIP SURGERY, THE 62MM CUP WOULD NOT SEAT INTO THE ACETABULUM. THE SURGEON REMOVED THE 62MM CUP AND IMPLANTED A 64MM CUP WITH NO ISSUES. THIS CAUSED A 5 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT STATED THE ISSUE WAS DISCOVERED DURING THE IMPACTION PHASE AND STATED THAT THE CUP WAS LOOSE INSIDE OF THE ACETABULUM AND WOULD NOT FIXATE. THE SURGEON THEN ELECTED TO MOVE UP TO THE LARGER SIZE CUP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207996 ↗
• MalfunctionJul 30, 2018Device Dislodged or Dislocated

  DURING A TOTAL HIP WHEN THE SURGEON WAS IMPLANTING THE CUP, THE INSERTER DISENGAGED FROM THE CUP. THE SURGEON USED A SECONDARY CUP AND A DIFFERENT INSERTER TO COMPLETE THE SURGERY. THERE WAS A TEN MINUTE DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731843 ↗